BLACKHEAD CLEANING SCRUB - 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.

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Drug Facts

Active ingredient

Salicylic acid  2%

Purpose

Acne treatment

Uses  for the treatment of acne

Warnings

For external use only.

Flammable. Keep away from fire or flame.

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 used unless 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   -Gently massage all over face 20-30

seconds, avoiding eye area    -Rinse thoroughly and pat dry

-Recommended for daily use

Other information store at room

temperature 68 - 86 F (20 - 30 C)

Inactive ingredients  water, cetearyl alcohol,

microcrystalline wax, paraffin, polysorbate 60, steareth-21,

aloe barbadensis leaf juice, propylene glycol, jojoba esters,

xanthan gum, menthyl lactate, ultramarines (blue)


copy of label

BLACKHEAD CLEANING SCRUB 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58194-031
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)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PARAFFIN (UNII: I9O0E3H2ZE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
STEARETH-21 (UNII: 53J3F32P58)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58194-031-01100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/11/2016
Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Weierya Daily Chemicals Factory420359333manufacture(58194-031)

Revised: 1/2016
Document Id: 425328b8-9552-462b-bb07-3646b8277680
Set id: bcf22bd6-2aef-4fb5-97ed-17e2217828fc
Version: 1
Effective Time: 20160113
 
Shanghai Weierya Daily Chemicals Factory