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4 Lidocaine Topical Anesthetic 40 mg/g Cream, 15 g — NDC 00536-1267-20 package photo

4 Lidocaine Topical Anesthetic 40 mg/g Cream, 15 g

by RUGBY LABORATORIES · 15 g in 1 BOX (0536-1267-20)
NDC 00536-1267-20
🏷️ FDA NDC (as labeled) 0536-1267-20 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Lidocaine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Apr 20, 2023 — Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains. (Bryant Ranch Prepack, Inc.) · FDA recall D-0556-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0536-1267-20
Product NDC 0536-1267
11-digit billing NDC 00536126720
NCPDP billing unit GM — per gram (weight)
RxCUI 1421893
UNII 98PI200987
UPC 0305361267209
Application # M017
SPL Set ID 63327e57-f4c8-4ae6-9d28-cef8697bbdcc
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-04-30
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE
GPI-14 90850060003720
GPI class Lidocaine
GCN Seq No 040262
GCN 95405
HICL code 010705
Ingredient (HICL) Lidocaine
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5H
Therapeutic class — specific (HIC3) Topical Local Anesthetics
AHFS code 72:00.00.00
AHFS class Local Anesthetics
FDB label name LIDOCAINE 4% CREAM
FDB brand name Lidocaine
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0536-1267-20 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00536-1267-20. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerRUGBY LABORATORIES
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedApr 2020
Product typeHuman Otc Drug
Portfolio149 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name LIDOCAINE 4% CREAM Ingredient Lidocaine
📗 Our plain-language guide HelloPharmacist
  • It's best to avoid using two lidocaine products at the same time unless your doctor says it's okay. When you use multiple products containing a local anesthetic, the total amount a...
  • Can I use a lidocaine patch and a lidocaine cream at the same time?
  • No — please don't do this. Heat significantly increases how much lidocaine is absorbed through your skin, which can push drug levels in your blood higher than they should be. Stick...
  • Can I put a heating pad on the area where I applied a lidocaine patch?
📖 Read our full Lidocaine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 7QWA1RIO01
    A synthetic form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the formulation from breaking down, helping the drug remain stable and effective during storage.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 97C5T2UQ7J
    Cholesterol is a fatty substance found naturally in animal tissues. In medications, it's used as an ingredient in liposomal formulations and lipid-based drug delivery systems to help encapsulate and stabilize active drugs for better absorption.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

14 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesaloe barbadensis leaf extract, benzyl alcohol, carbomer homopolymer, cetyl alcohol, cholesterol, di-alpha tocopherol, glycerin, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, stearic acid

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly $0.597 $8.95 / 15 g
Medicaid paysCMS SDUD · 12 mo $0.7486 $11.23 / 15 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $1.156 $0.570
Flat over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Lidocaine 4 g/100g 00536-1357-95 Rugby 1 tube $0.410 Availability likely save 31%
Lidocaine 4% Topical Anesthetic Cream 4 g/100g 83720-0523-01 Oncor 1 tube $0.482 Availability likely save 19%
4 Lidocaine Topical Anesthetic 40 mg/gthis 00536-1267-20 RUGBY 15 g $0.597 Availability likely
Lidocaine 40 mg/g 39328-0024-15 Patrin 1 tube $0.597 Availability likely
Numbing Pain Relief 4 g/100g 00363-6261-07 Walgreen 1 applicator FDA listed
Lmx4 40 mg/g 00496-0882-05 Ferndale 5 g FDA listed
Lidocaine 40 mg/g 10135-0672-96 Marlex 1 tube FDA listed
Anecream 4 g/100g 24357-0701-06 Focus 5 tubes FDA listed
Meijer Analgesic Lidocaine Topical Analgesic 40 mg/g 41250-0518-01 Meijer 1 bottle FDA listed
Lidocaine 4 g/100g 42291-0399-30 AvKARE 1 tube FDA listed
Pain free IV 4 g/100mL 54723-0008-01 Sambria 4 ml FDA listed
Painless Tattoo 2 4 g/100mL 54723-0016-01 Sambria 4 ml FDA listed
NeuroMed Topical Anesthetic 7 40 mg/g 54723-0300-04 Sambria 4 g FDA listed
Family Wellness Pain Relief with Lidocaine 40 mg/g 55319-0822-50 FAMILY 1 tube FDA listed
Lidocaine 40 mg/g 58980-0824-05 Stratus 1 tube FDA listed
Burn Relief Professional Bio-Kool 4 g/100g 61566-0201-04 Kool-Down 113 g FDA listed
Desert Harvest RELEVEUM 40 mg/mL 69145-0201-04 Desert 118 ml FDA listed
Lidocaine Anesthetic Cream 4 g/100g 69375-0005-30 Nationwide 1 tube FDA listed
Tylenol Precise Warming Pain Relieving 40 mg/g 69968-0794-04 Kenvue 1 tube FDA listed
Tylenol Precise Pain Relieving 40 mg/g 69968-0795-04 Kenvue 1 tube FDA listed
Blue-Emu Lidocaine Pain Relief Cream 40 mg 69993-0350-03 Kingsway 1 tube FDA listed
Lidocaine Cream, 4% 4 g/100g 71085-0075-19 IPG 119 g FDA listed
Deeveeant Numb 40 mg/g 71383-0014-02 Valekista 1 tube FDA listed
MediNumb 40 mg/g 71383-0024-02 Valekista 1 tube FDA listed
Asper Flex 4 g/100g 71399-0049-01 Akron 15 g FDA listed
Lidocaine 4% 4 g/100g 71800-0026-06 Innovida 58.5 g FDA listed
Lidozall 4 g/100g 72835-0004-20 V2 20 packets FDA listed
Lidocaine 4% Topical Anesthetic Cream 4.27 g/100g 73715-0001-01 Mohnark 30 g Discontinued
Meijer Pain Relief Cream 4 g/100g 79481-0048-02 Meijer 76.5 g FDA listed
Lidocaine 40 mg/g 80425-0351-01 Advanced 1 tube FDA listed
Lidocaine 4% Cream 40 mg/g 82461-0419-30 Medcore 1 tube FDA listed
AUVON Pain Relief Cream 4 g/100g 83391-0009-01 SHENZHEN 57 g FDA listed
RelaxInk LIDOCAINE 4 g/100g 83714-0004-01 Hambli 1 tube FDA listed
ELAIMEI Numbing Cream 4 g/100mL 83804-0005-01 Shenzhen 1 bottle FDA listed
Tktalker Numbing 4 g/100g 83804-0113-01 Shenzhen 50 g FDA listed
Dcsily Numbing Cream 4 g/100g 83818-0034-01 Shenzhen 50 g FDA listed
4% TATTOO Numb Cream 100 mg/g 84019-0030-01 Shengnan 30 g FDA listed
Signature Pain Relief Cream 40 mg/g 84019-0044-01 Shengnan 30 g FDA listed
Nekvnro LIDOCAINE 4% Tattoo numbing cream set 4 g/100g 84844-0018-01 Guoyu 2 tubes Discontinued
VBBV Tattoo Numbing 40 mg/mL 84867-0014-01 Jiashen 60 ml FDA listed
Black Cobra Tattoo Numbing Cream 4% Lidocaine .04 g/g 84938-0002-01 Foshan 20 g FDA listed
Jakwork Numbing Cream 4 g/100g 85150-0007-01 Guangzhou 50 g FDA listed
Healmusz Numbing 4 g/100g 85248-0032-01 Jiangxi 50 g FDA listed
Nieapf NUMBING 4 g/100g 85248-0046-01 Jiangxi 65 g FDA listed
Subleef NUMBING 4 g/100g 85248-0052-01 Jiangxi 30 g FDA listed
Sylvirene Numbing 4 g/100g 85248-0070-01 Jiangxi 50 g FDA listed
ANIXIKE Numbing 4 g/100g 85248-0088-01 Jiangxi 30 g FDA listed
Dermfree Numbing 4 g/100g 85248-0121-01 Jiangxi 50 g FDA listed
ANIXIKE Numbing 4 g/100g 85248-0166-01 Jiangxi 30 g FDA listed
YYSDMVY NUMBING Cream 4 g/100g 85248-0209-01 Jiangxi 60 g FDA listed
Tattoo numbing cream 4 g/100g 85284-0001-01 BLOOMWELL 50 g FDA listed
Topical Cream 4 g/100g 85284-0002-01 BLOOMWELL 50 g Discontinued
Numbing Cream 4 g/100g 85284-0003-01 BLOOMWELL 50 g Discontinued
numbing cream MAXIMUM STRENGTH 4 g/100g 85284-0006-01 BLOOMWELL 50 g Discontinued
Veiurkiu External Analgesic Cream 4 g/100g 85284-0011-01 BLOOMWELL 50 g FDA listed
Numbing Cream 40 mg/g 85569-0001-01 100 50 g FDA listed
Numbing Cream 4 mg/100mL 85569-0002-01 100 50 ml FDA listed
SCHOELIF Numbing Cream 4 g/100g 85817-0001-01 Guangzhou 50 g FDA listed
Aouiv 4% Lidocaine Numbing Cream 4 g/100g 85817-0003-01 Guangzhou 60 g FDA listed
Numbing Creams 4 g/100g 85881-0001-01 Yongchun 50 g FDA listed
Black Cobra 4% Lidocaine Numbing Cream 40 mg/g 85924-0001-02 BLACKCOBRASUPPLY, 1 tube Discontinued
Swiftalyn Numbing Cream 4 g/100g 87013-0002-01 GENUINE 50 g FDA listed
Morovan 4 g/100g 87800-2624-01 HONG 1 can FDA listed
Greencaine Blast 40 mg/g 69747-0040-01 ALMA 113 g FDA listed
Bed Bug Instant Bite Relief 40 mg/g 70466-0001-01 P.F. 1 tube FDA listed
BENGAY Tropical Jasmine 40 mg/g 69968-0614-03 Kenvue 1 tube FDA listed
Hush Anesthetic 40 mg/g 49947-0002-02 HUSH 56.7 g FDA listed
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
On the market since
Apr 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic versions listed
see equivalents
Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00536-1267-20, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
18.8K
Units reimbursed last 4 qtrs
682.1K
Gross reimbursed last 4 qtrs
$510.6K
Avg / prescription
$27.09
Avg / unit
$0.7486
Latest quarter Q4 2025
7.3KRx
Medicaid pays / g
$0.7486
gross reimbursed
vs
NADAC / g
$0.5969
acquisition cost
=
Spread
+$0.1517
+25% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
61% FFS 39% MCO
Fee-for-service · 11,526 Rx Managed care · 7,323 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 3,671 units · 64.0 per 100k residents MN Wisconsin: no data reported WI Michigan: 5,250 units · 52.3 per 100k residents MI New York: 67,047 units · 343 per 100k residents NY Vermont: 915 units · 141 per 100k residents VT New Hampshire: no data reported NH Oregon: 255 units · 6.0 per 100k residents OR Nevada: 25,200 units · 789 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,650 units · 13.1 per 100k residents IL Indiana: 4,108 units · 59.9 per 100k residents IN Ohio: 39,948 units · 339 per 100k residents OH Pennsylvania: 52,947 units · 409 per 100k residents PA New Jersey: 60,792 units · 654 per 100k residents NJ Massachusetts: no data reported MA California: 360,501 units · 925 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 5,953 units · 301 per 100k residents NE Missouri: no data reported MO Kentucky: 8,073 units · 178 per 100k residents KY West Virginia: 255 units · 14.4 per 100k residents WV Virginia: 4,155 units · 47.7 per 100k residents VA Maryland: 6,247 units · 101 per 100k residents MD Connecticut: 11,700 units · 323 per 100k residents CT Rhode Island: 600 units · 54.8 per 100k residents RI Arizona: 11,280 units · 152 per 100k residents AZ New Mexico: 630 units · 29.8 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 2,310 units · 43.0 per 100k residents SC Delaware: 255 units · 24.7 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 300 units · 2.7 per 100k residents GA D.C.: 8,096 units · 1,192 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.71,192
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 D.C. 1,192 /100k
2 California 925 /100k
3 Nevada 789 /100k
4 New Jersey 654 /100k
5 Pennsylvania 409 /100k
6 New York 343 /100k
7 Ohio 339 /100k
8 Connecticut 323 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lidocaine (matched by generic name) — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lidocaine. CMS lists 8 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$53.12M
Claims incl. refills
593.7K
Beneficiaries
367.9K
Spend / beneficiary
$144.39
Spend / claim
$89.46
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
00536-1267-20 You're viewing this 15 g in 1 BOX (0536-1267-20) 2020-04-30 Active

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 20 words

Uses temporarily relieves pain and itching due to: minor cuts minor scrapes sunburn minor skin irritations minor burns insect bites

⏱️ Dosage and Administration 26 words

Directions Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily. Children under 2 years: Consult a doctor.

⚠️ Warnings 97 words

Warnings For external use only. When using this product do not use in or near the eyes do not use in large quantities, particularly over raw surfaces or blistered areas. Stop use and ask a doctor if Allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase Do not use over large areas of the body.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 8 words

Active ingredient Lidocaine 4% W/W Purpose Topical Analgesic

🧪 Inactive Ingredients 28 words

Inactive ingredient aloe barbadensis leaf extract, benzyl alcohol, carbomer homopolymer, cetyl alcohol, cholesterol, di-alpha tocopherol, glycerin, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, stearic acid

🎯 Purpose 3 words

Purpose Topical Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.