ANTI-BLEMISH CLEANSER- salicylic acid cream 
Shanghai Weierya Daily Chemicals Factory

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 2%

Purpose

Acne treatment

Uses  for the treatment of acne

Warnings

For external use only.

Avoid contact with eyes & lip, if contact

occurs, flush thoroughly with water.

Ask a doctor or pharmacist before using

other topical acne medications at the same time

or immediately following use of this product. May increase

dryness or irritation of the skin. If this occurs, only one

medication should be usedunless directed

by a doctor.

When using this product apply to affected

area only. Do not use on broken skin or

apply to large areas of the body.

Keep out of reach of children. If

swallowed, get medical help or contact a

Poison Control Center right away.

Directions

-Wet face, squeeze into hands and apply to face

-Gently massage all over face avoiding eye area

-Rinse thoroughly with water

-Recommended for daily use

Other information  store at room

temperature 68 - 86 F (20 - 30 C)

Inactive ingredients  water, cetearyl alcohol, glycerin,

ppg-15 stearyl ether, ethylhexyl palmitate, steareth-21, potassium

cetyl phosphate, polysorbate 60, xanthan gum, disodium EDTA,

methanol, benzalkonium chloride, sodium hydroxide, fragrance

image description

ANTI-BLEMISH CLEANSER 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58194-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
steareth-21 (UNII: 53J3F32P58)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHANOL, (((1-METHYL-2-(5-METHYL-3-OXAZOLIDINYL)ETHOXY)METHOXY)METHOXY)- (UNII: S78T1JQV6B)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58194-054-01113 g in 1 TUBE; Type 0: Not a Combination Product07/17/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/17/2016
Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Weierya Daily Chemicals Factory420359333manufacture(58194-054)

Revised: 7/2016
Document Id: 42ab830f-8e52-4c3a-b124-3f57186fc921
Set id: eb4f8fd3-48f9-4e62-9942-1878217134b4
Version: 1
Effective Time: 20160717
 
Shanghai Weierya Daily Chemicals Factory