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NDC 70000-0099-01 Leader Lidocaine 4 g/100mL Details

Leader Lidocaine 4 g/100mL

Leader Lidocaine is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by CARDINAL HEALTH. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	70000-0099
Product ID	70000-0099_d3499047-8807-7fe9-e053-2a95a90a19bb
Associated GPIs
GCN Sequence Number	080206
GCN Sequence Number Description	lidocaine HCl LIQD ROLON 4 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	46917
HICL Sequence Number	001478
HICL Sequence Number Description	LIDOCAINE HCL
Brand/Generic	Generic
Proprietary Name	Leader Lidocaine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	g/100mL
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	CARDINAL HEALTH
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0099-01 (70000009901)

Pricing Information	N/A
NDC Package Code	70000-0099-1
Billing NDC	70000009901
Package	1 BOTTLE, PLASTIC in 1 CARTON (70000-0099-1) / 73 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2021-10-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cece6765-0e2f-5ce9-e053-2995a90a3758 Details

Active Ingredient

Lidocaine HCl 4%

Purpose

Topical analgesic

Uses

temporarily relieves pain and itching due to:

minor burns
sunburn
minor cuts
scrapes
insect bites
minor skin irritations

Warnings

For external use only

Do not use in large quantities, particularly over raw surfaces or blistered areas

When using this product do not get into eyes

Stop use and ask a doctor if

condition gets worse
symptoms last for more than 7 days
symptoms clear up and occur again within a few days

Flammable •Keep away from fire or flame

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
children under 12 years: ask a doctor

Other information

store between 20 °C and 25 °C (68 °F and 77 °F)

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,

C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21

Questions or comments?

call 515-276-1586

Principal display panel

Leader

NDC 70000-0099-1

Maximum Strength

Lidocaine

Pain Relief

Liquid

Lidocaine HCl, 4% Topical Analgesic

No Mess

Applicator

Compare to

Aspercreme

Lidocaine liquid

active ingredient

100% Money Back Guarantee

2.5 Fl oz (73 mL)

INGREDIENTS AND APPEARANCE

LEADER LIDOCAINE

lidocaine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0099
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
STEARETH-21 (UNII: 53J3F32P58)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0099-1	1 in 1 CARTON	10/20/2021
1		73 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/20/2021

Labeler - CARDINAL HEALTH (063997360)

Registrant - Weeks & Leo Co., Inc. (005290028)

Name	Address	ID/FEI	Business Operations
Establishment
Weeks & Leo Co., Inc.		005290028	manufacture(70000-0099)

Revised: 1/2022

Document Id: d3499047-8807-7fe9-e053-2a95a90a19bb

Set id: cece6765-0e2f-5ce9-e053-2995a90a3758

Version: 2

Effective Time: 20220105