GENITAL WART REMOVAL ONITMENT- salicylic acid ointment

Genital wart removal onitment by

Drug Labeling and Warnings

Genital wart removal onitment by is a Otc medication manufactured, distributed, or labeled by Hengyang Chuangjiujia Trading Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Genital wart removal onitment

ACTIVE INGREDIENT

Salicylic acid 40%

PURPOSE

WART REMOVAL

INDICATIONS & USAGE

Use For the removal ofcommon warts. Thecommon wart is easilyrecognized by the rough"cauliflower-like" appear-ance of the surface.

WARNINGS

For external use onlyIf the product gets intoeyes, flush with water for15 minutes. Avoid inhalingvapours

DO NOT USE

Do not use on irfitatedskinor on any area that isinfected or reddened m ifyou are diabetic or if youhave poor blood circulationm piles birthmarkssm warts with hair growingfrom them

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

Keep out ofreach of children. lfswallowed, get medical helpor contact a Poison ControlCenter right away.

STOP USE

Stop use & ask a doctor ifdiscomfort persists

DOSAGE & ADMINISTRATION

Wash affected area (maysoak wart in warm waterfor 5 minutes if desired)
Dry area thoroughly.
Apply small amount byhand to covereach wart.Let dry.
Repeat this proceduretwice dailyas needed forup to 12 weeks

INACTIVE INGREDIENT

Deionized Water
Hydrogen Peroxide
Birch Oil
Petroleum
C13-14
Methyl Salicy-late
Cetearyl Alcohol
Mineral 0il
Ceteareth-20
Sodium Lauryl Sulfate
Diazolidinyl Urea
EDTA Disodium Salt
lodopropynyl Butylcarbamate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GENITAL WART REMOVAL ONITMENT 
salicylic acid ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84735-001
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
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
BETULA PENDULA TAR OIL (UNII: 7JK2RXJ8G7)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYL SALICYLATE (UNII: LAV5U5022Y)
LIQUID PETROLEUM (UNII: 6ZAE7X688J)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84735-001-01	1 in 1 BOX	09/13/2024
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M028	09/13/2024

Labeler - Hengyang Chuangjiujia Trading Co., Ltd. (977292157)

Establishment
Name	Address	ID/FEI	Business Operations
Hengyang Chuangjiujia Trading Co., Ltd.		977292157	manufacture(84735-001)