Drug Facts

Active Ingredient

Lidocaine 2%

Purpose

Anorectal

Use (s)

For temporary relief of pain, soreness or burning in the peritanal area.

Warnings:

For external use only.

Do not use

this product with a mechanical device. 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. Do not apply onto cracked or broken skin.

Keep out of reach of children.

In case of any bleeding, discontinue use and consult a doctor. As with any drug, consult a health care professional.

Directions

Cleanse affected area with mild soap and water. Gently dry before application. Apply externally to the affected area up to 6 times daily.

Other Information:

Store at room temperture 68-77 °F (20-25 °C).
Do not use if temper evident seal on the outside of the container is broken or missing.

Inactive Ingredients:

Water, Dimethicone, Cetearyl Alcohol, Caprylic/Capric Triglyceride, Lidocaine, Glyceryl Stearate, Propylene Glycol, Ceteareth-20, 1,2-Hexanediol, Hydroxyacetophenone, Dimethiconal, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Sodium Hydroxide.

Package Labeling:

Label

BRAZZERS ANAL DESENSITIZING
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83553-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83553-001-00	29.6 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/06/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M015	07/06/2023

Labeler - Metro Media Ent (089682591)

Name	Address	ID/FEI	Business Operations
Establishment
Bath Concept Cosmetics (Dongguan) Co., Ltd		529623933	manufacture(83553-001)

Brazzers Anal Desensitizing Cream