ACNE WIPES- salicylic acid swab 
JIANGSU TERRA MEDICAL TECHNOLOGY 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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Active ingredient

Sallcylic Acid 0.5%

Purpose

acne treatment

Use

for the treatment of acne.

Warnings

for external use only

ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately

over large areas of the body following use of this product.

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time .if irritation occurs,only use one topical acne medication at a time.

avoid contact with eyes,if contact occurs ,flush thoroughly with water.

Keep out of reach of children .if swallowed,get medical help or contact a Poison Control Center reght away.

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

Directions

use daily to get clear skin.

clean the skin thoroughly before applying this product.

cover the entire affected area one to three times daily.

because excessive drying of the skin may occur,start with one application daily ,then gradually increase to two or three times daily if needed or as directed by a doctor .

if bothersome dryness or peeling occurs ,reduce application to once a day or every other day.

throw away cloth(do not flush)

water ,cetearyl isononaneate,ceteareth-20,fregrance,cetearyl alcohol,glyceryl stearate,glycerin,ceteareth-12,cetyl palmitate,proplyene glycol,methjylparaben,disodium EDTA,propylparaben,2-bromo-2-nitropropane-1,3-Diol

label

ACNE WIPES 
salicylic acid swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69733-566
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
CETEARETH-2 PHOSPHATE (UNII: 8NSU66JGZR)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
BRONOPOL (UNII: 6PU1E16C9W)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69733-566-0830 in 1 PACKAGE
10.623 mg in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/30/2015
Labeler - JIANGSU TERRA MEDICAL TECHNOLOGY CO LTD (421340473)
Establishment
NameAddressID/FEIBusiness Operations
JIANGSU TERRA MEDICAL TECHNOLOGY CO LTD421340473manufacture(69733-566)

Revised: 9/2015
Document Id: 20f735c6-7950-069b-e054-00144ff8d46c
Set id: 20f735c6-794a-069b-e054-00144ff8d46c
Version: 1
Effective Time: 20150929
 
JIANGSU TERRA MEDICAL TECHNOLOGY CO LTD