WET WIPES- salicylic acid swab
HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.

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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61312004

Active ingredient

salicylic acid 0.5%

Purpose

acne treatment

Use

for the treatment of acne

Warnings

for external use only
when using this product
with other topical acne medications ,at the same time or immediately afterwards ,increased skin dryness ,redness or
irritation may occur .If this happens ,only one medication should be used unless directed by a doctor.
avoid contact with eyes .if contact occurs, rinse thoroughly with water. keep away from mouth and lips.
stop use and ask doctor if skin irritation occurs.
Keep out of reach of children ,If swallowed ,get medical help or contact a Poison Control Center immediately.

Keep out of reach of children

Keep out of reach of children ,If swallowed ,get medical help or contact a Poison Control Center immediately.

Directions

cleanse skin thoroughly before applying medication ,remove wipe ,unfold and wipe over entire affected area.
reseal label on package to maintain freshness.

aqua (water),glycerin, propylene glycol , dodecyl polyglucoside, polysorbate 20,HEXYLENE GLYCOL , BENZYL ALCOHOL ,SODIUM LAURAMINOPROPIONATE ,ALOE BARBADENSIS(ALOE VERA )EXTRACT ,WHITE TEA EXTRACT ,CHAMOMILLA RECUTITA(CHAMOMILE)EXTRACT ,GLYDANT DMDM H,PHENOXYETHANOL ,PEG-40 HYDROGENATED CASTOR OIL,TOCOPHERYL ACETATE(VITAMIN E) ,DISODIUM EDTA,IODOPROPYNYL BUTYLCARBAMATE

image description

WET WIPES
salicylic acid swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61312-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DODECYL PROPIONATE (UNII: 7G537BMD9L)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM LAURAMINOPROPIONATE (UNII: X5NJA9HXPU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TEA LEAF OIL (UNII: VC855RRT77)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-40 HYDROGENATED LANOLIN (UNII: 959P5CXE48)
TOCOPHERYL RETINOATE (UNII: 0WN694NBMM)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61312-004-01	35 in 1 BAG	01/01/2018
1		0.00054 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358B	02/25/2015

Labeler - HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. (526890634)

Name	Address	ID/FEI	Business Operations
Establishment
HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.		526890634	manufacture(61312-004)