ACNE TREATMENT CLEAR GEL - MAXIMUM STRENGTH- salicylic acid gel 
McCure Health Solutions Inc.

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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Acne Treatment Clear Gel - Maximum Strength

Drug Facts

Active ingredient

Salicylic Acid 0.5%

Purpose

Acne Treatment

Uses

for the treatment and prevention of acne pimples

Warnings

for external use only.

do not use

if you have sensitive skin or are sensitive to Salicylic Acid.

When using this product

avoid contact with eyes, lips and mouth.

  • if using with other topical acne medications, at the same time or immediately following use of this product, increased dryness of the skin may occur. If this occurs, only one medication should be used unless otherwise directed by a doctor. Skin irritation may occur characterized by redness, burning, itching, peeling or possible swelling. Mild irriation may be reduced by using this product less frequently or lower concentration. Stop  use and ask a doctor if skin irritation becomes severe.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, ger medical help or contact a Poison Control Center right away.

Directions

Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to three times day. Use to prevent new pimples from forming.

Other information

Inactive ingredients

DMDM HYDANTOIN, GLYCERIN, HYDROXYETHYL CELLULOSE, METHYLPARABEN, PROPYLPARABEN, PROPYLENE GLYCOL, WATER

Product Label

ACNE TREATMENT

ACNE TREATMENT CLEAR GEL - MAXIMUM STRENGTH 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52486-010-281 in 1 CARTON03/27/2015
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/27/2015
Labeler - McCure Health Solutions Inc. (053034873)
Establishment
NameAddressID/FEIBusiness Operations
Jiangsu Dedi Medical Device Co., Ltd..544458936manufacture(52486-010)

Revised: 12/2016
Document Id: 44bd9411-0c34-1729-e054-00144ff88e88
Set id: b6d663c4-c488-463c-babf-c32fe9ea024b
Version: 4
Effective Time: 20161228
 
McCure Health Solutions Inc.