111MEDCO 2% SALICYLIC ACID CLEANSING BAR- salicylic acid soap 
111MedCo LLC

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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111MedCo 2% Salicylic Acid Cleansing Bar

Drug Facts

Active ingredient

Salicylic acid 2%

Purpose

Acne treatment

Uses

Warnings

For external use only

When using this product

skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a  healthcare provider.

Keep out of reach of children.

If swallowed, get medial help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Sodium palmate, sodium cocoate*, sodium palm kernelate*, agua, glycerin, pink grapefruit extract, sodium chloride, pentasodium pentetate.
(*may contain this ingredient)

Package Labeling: 111MedCo 2% Salicylic Acid Cleansing Bar, 4oz/113g (72811-000-04)

Label

111MEDCO 2% SALICYLIC ACID CLEANSING BAR 
salicylic acid soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72811-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM PALMATE (UNII: S0A6004K3Z)  
SODIUM COCOATE (UNII: R1TQH25F4I)  
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72811-000-04113 g in 1 CARTON; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D07/01/2022
Labeler - 111MedCo LLC (065115643)

Revised: 10/2022
Document Id: eb46ea04-adf2-2290-e053-2995a90a91c9
Set id: 6ba7dd8f-b59f-4dfb-b55e-c7fe65a54d8a
Version: 2
Effective Time: 20221017
 
111MedCo LLC