BATH AND BEAUTY  CHARCOAL ACNE SCRUB- salicylic acid gel 
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI

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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Bath & Beauty Deep Pore Charcoal Acne Scrub

Active ingredient

Salicylic acid 1%

Purpose

Acne treatment

Uses

Warnings

For external use only.

When using this product

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

Directions

Other information

store at room temperature

Inactive ingredients

Water, Glycerin, Sodium laureth Sulfate, Cocamidopropyl Betaine, Sorbitol,  Synthetic Wax, Microcrystalline Wax, Charcola Powder , Xanthan gum, fragrance, Sodium hydroxide, menthol, polyquaternium-39, charcoal powder, Disodium EDTA, Iodopropynyl Butylcarbamate,  Sodium Benzoate

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BATH AND BEAUTY   CHARCOAL ACNE SCRUB
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76772-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.3 g  in 91 g
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: X2NH1K9F8K)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MENTHOL (UNII: L7T10EIP3A)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76772-025-9191 g in 1 TUBE; Type 0: Not a Combination Product03/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/10/2021
Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
Registrant - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
Establishment
NameAddressID/FEIBusiness Operations
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI533120570manufacture(76772-025)

Revised: 3/2021
Document Id: bd3aecf5-3824-53d6-e053-2a95a90a83db
Set id: f4324718-78f6-48cd-9977-48fc7cf1a1cd
Version: 2
Effective Time: 20210310
 
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI