QUICK NUMB- lidocaine cream
Clinical Resolution Laboratory, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses:

For the temporary relief of local and anorectal discomfort associated with anorectal discomfort or inflammation.

Warnings

(For external use only)

Do not use this product if

pregnant or breast-feeding, ask a health professional before use.
in case of accidental overdose, get medical help or contact the Poison Control Center immediately.
tamper-evident "Do not use this product" if seal is broken or missing.

When using this product

Do not exceed the recommended daily dosage unless directed by a doctor.
Certain persons can develop allergic reactions to ingredients in this product.
Do not put this product into the rectum by using fingers or any medical device or applicator.

Stop use and ask a doctor if

The symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Keep out of reach of children

In case of accidental ingestion, seek medical attention immediately.

Directions

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

Other Information

Keep away from direct sunlight or heat.
Store in room temperature (59-86°F / 15-30°C).

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

image description

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: 11/2021

Document Id: d12b7c5e-3944-a3ba-e053-2a95a90a0a75

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

Version: 1

Effective Time: 20211119

Clinical Resolution Laboratory, Inc.