GENITAL WART REMOVAL ONITMENT- salicylic acid 40% cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

SALICYLIC ACID 40%

PURPOSE

Wart Remove

INDICATIONS & USAGE

Use For the removal of common warts. The common wart is easily recognized by the rough"cauliflower-like" appear-ance of the surface.

WARNINGS

For external use only If the product gets into eyes, flush with water for 15 minutes. Avoid inhaling vapours.

DO NOT USE

Do not use on irfitated skinor on any area that is infected or reddened m if you are diabetic or if you have poor blood circulationm piles birthmarkssm warts with hair growing from them

STOP USE

Stop use & ask a doctor if discomfort persists

KEEP OUT OF REACH OF CHILDREN

If pregnant or breastfeed-ing, ask a health profession-al before use. Keep out of reach of children. Ifswallowed, get medical helpor contact a Poison ControlCenter right away.

DOSAGE & ADMINISTRATION

Wash affected area (may soak wart in warm water for 5 minutes if desired)
Dry area thoroughly.
Apply small amount by hand to covereach wart.
Let dry.
Repeat this procedure twice dailyas needed for up to 12 weeks

INACTIVE INGREDIENT

HYDROGEN PEROXIDE
B ETULA PENDULA TAR OIL
MINERAL OIL
WATER
C 13-14 ISOPARAFFIN
IO DO PROPYNYL BUTYLCARBAMATE
METHYL SALICYLATE
LIQUID PETROLEUM
DIAZOLIDINYL UREA
EDETATE DISODIUM
CETOSTEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
SODIUM LAURYL SULFATE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GENITAL WART REMOVAL ONITMENT 
salicylic acid 40% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87278-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.4 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
BETULA PENDULA TAR OIL (UNII: 7JK2RXJ8G7)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LIQUID PETROLEUM (UNII: 6ZAE7X688J)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MINERAL OIL (UNII: T5L8T28FGP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87278-011-01	30 g in 1 BOTTLE; Type 0: Not a Combination Product	04/16/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M026	04/16/2026

Labeler - Guangxi Keyun E-commerce Co., Ltd. (517165491)

Establishment
Name	Address	ID/FEI	Business Operations
Guangxi Keyun E-commerce Co., Ltd.		517165491	manufacture(87278-011)