ADVANCED ACNE SPOT TREATMENT - salicylic acid gel 
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

-Cleanse skin thoroughly before applying.

-Cover the entire affected area with a thin layer 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 directed by a doctor. If bothersome dryness or

peeling occurs, reduce application to once a day or

every other day.

Other information store at room

temperature 68 - 86 F (20 - 30 C)

Inactive ingredients  alcohol, ammonia,

benzalkonium chloride, butylene glycol, dimethicone,

disodium EDTA, glycerin, hamamelis virginiana extract,

laureth-7, menthyl lactate, paraffin, phenoxyethanol,

polyacrylamide, portaluca oleracea extract, propylene

glycol, water, xanthan gum

copy of label

ADVANCED ACNE SPOT TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58194-030
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
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
LAURETH-7 (UNII: Z95S6G8201)  
METHYL LACTATE, (-)- (UNII: 0379G9C44S)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)  
PURSLANE (UNII: M6S840WXG5)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58194-030-011 in 1 CARTON
121 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(58194-030)

Revised: 1/2016
Document Id: 83981039-7f29-40e3-83fa-4496ae3c7e03
Set id: ee4224cb-6e17-496d-8dc9-47dcfc3c5c4a
Version: 1
Effective Time: 20160110
 
Shanghai Weierya Daily Chemicals Factory