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NDC 63742-0111-01 Quick Numb 50 mg/g Details

Quick Numb 50 mg/g

Quick Numb is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Clinical Resolution Laboratory, Inc.. The primary component is LIDOCAINE.

Product Information

NDC	63742-0111
Product ID	63742-111_e3514af1-f9bc-c251-e053-2a95a90ac80e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Quick Numb
Proprietary Name Suffix	n/a
Non-Proprietary Name	LIDOCAINE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	50
Active Ingredient Units	mg/g
Substance Name	LIDOCAINE
Labeler Name	Clinical Resolution Laboratory, Inc.
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2023-12-31

Package

Package Images

NDC 63742-0111-01 (63742011101)

Pricing Information	N/A
NDC Package Code	63742-111-01
Billing NDC	63742011101
Package	119 g in 1 BOTTLE (63742-111-01)
Marketing Start Date	2021-11-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aceef61c-05eb-4fac-88dc-5017da5e964c Details

DRUG FACTS

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses:

For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation
For the temporary relief of pain, burning and soreness.

Warnings

If condition worsens or does not improve within 7 days, consult a doctor.
Do not exceed the recommended daily dosage unless directed by a doctor.
In case of bleeding, consult a doctor promptly.
Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

Directions

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.
Apply externally to the affected area up to 6 times daily.

Other Information

Keep away from direct sunlight or heat.
Store at room temperature 15°-30°C (59°-86°F).
This package is child-resistant. Keep out of reach of children.
In case of accidental overdose or ingestion, call a doctor or poison control center immediately.
Do not use this product if seal is broken or missing.

Inactive Ingredients

Allanloin, Aloe Barbadensis Leaf Juice, Benzyt Alcohol,Carbomer, Cholesterol, Dlmethyt lsosorbide, DisodiumEDTA, Hydrogenated Polydecene, Lecithin, NeopenlytGlycol Dicaprylale/Dicaprate. Propylene Glycol, Water,Sodium Polyacrytate, Tocopheryt Acetate, Trideceth-6,Triethanolamine

Product label

INGREDIENTS AND APPEARANCE

QUICK NUMB

lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63742-111
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CHOLESTEROL (UNII: 97C5T2UQ7J)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63742-111-01	119 g in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	11/01/2021

Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Name	Address	ID/FEI	Business Operations
Establishment
Clinical Resolution Laboratory, Inc.		825047942	manufacture(63742-111)

Revised: 7/2022

Document Id: e3514af1-f9bc-c251-e053-2a95a90ac80e

Set id: aceef61c-05eb-4fac-88dc-5017da5e964c

Version: 2

Effective Time: 20220708