Wet Wipes: Package Insert and Label Information

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.

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

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WET WIPES
salicylic acid swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61312-006
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PROPYLENE GLYCOL
DODECYL PROPIONATE
POLYSORBATE 20
HEXYLENE GLYCOL
BENZYL ALCOHOL
SODIUM LAURAMINOPROPIONATE
ALOE VERA LEAF
TEA LEAF OIL
CHAMOMILE FLOWER OIL
DMDM HYDANTOIN
PHENOXYETHANOL
PEG-40 HYDROGENATED LANOLIN
TOCOPHERYL RETINOATE
DISODIUM EDTA-COPPER
IODOPROPYNYL BUTYLCARBAMATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61312-006-01 35 POUCH in 1 BAG contains a POUCH
1 0.0027 g in 1 POUCH This package is contained within the BAG (61312-006-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part358B 02/25/2015
Labeler — HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. (526890634)
Establishment
Name Address ID/FEI Operations
HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. 526890634 manufacture (61312-006)

Revised: 01/2018 HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.

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