ACNE TREATMENT PADS- salicylic acid patch 
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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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 throoughly 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

-Cleanse the skin thoroughly before applying medication

-Use the pad to wipe the entire affected area one to three times daily

-If bothersome dryness or peeling occurs, reduce application to once a day or every other day

-Do not peave pad on skin for an extended period of time.

Other information  store at room

temperature 68 - 86 F (20 - 30 C)

Inactive ingredients  water, SD

alcohol, glycerin, trideceth - 8,

PEG-12 dimethicone, hamamelis virginiana

flower (witch hazel) water, disodium EDTA,

benzalkonium chloride, sodium hydroxide,

fragrance

image description

ACNE TREATMENT PADS 
salicylic acid patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58194-044
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
TRIDECETH-8 (UNII: FZH06801NX)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
HAMAMELIS VIRGINIANA FLOWER WATER (UNII: 222MYC9QUV)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58194-044-5050 in 1 JAR07/17/2016
1NDC:58194-044-012 mL in 1 PATCH; Type 0: Not a Combination Product
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(58194-044)

Revised: 7/2016
Document Id: 89cb9b4a-194d-479e-9d59-a0a967f99bd2
Set id: 49064b32-0cec-45de-9fe1-44f55edf6d14
Version: 1
Effective Time: 20160717
 
Shanghai Weierya Daily Chemicals Factory