SKINCOACH TREAT- benzoyl peroxide gel 
SKIN COACH SL.

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                               Purpose

Benzoyl Peroxide USP 2.5%------------ Anti-acne

Uses

Topical acne medication.

Warnings

When using this product avoid unnecessary sun exposure and use a sunscreen.For external use only ■ Keep away from eyes, lips, and mouth ■ If irritation develops discontinue use and consult a doctor ■ 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 consult a doctor. ■May bleach fabrics.

Keep out of the reach of childen. If swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

■ Cleanse the skin thoroughly belore applying. ■ Apply a thin layer daily,then gradually increase to two or three times daily. ■ If bothersome drying or peeling occurs, reduce applications. ■ If going outside, use a sunscreen. If initation or sensitivity develops, discontinue use of both products and consult a doctor.

Inactive ingredients

Carbomer, Purified Water, Sodium hydroxymethylglycinate, Sodium Lauroyl sarcosinate, Stearic Acid.

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label

image description

SKINCOACH TREAT 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73047-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73047-002-0157 g in 1 TUBE; Type 0: Not a Combination Product05/21/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D05/21/2019
Labeler - SKIN COACH SL. (468534978)
Registrant - SKIN COACH SL. (468534978)
Establishment
NameAddressID/FEIBusiness Operations
Topiderm Inc. II078841698manufacture(73047-002)

Revised: 5/2019
Document Id: 7d337db6-abf3-4795-86ff-c9aa67bf9a69
Set id: 1a553d88-5719-40b1-983c-0eb849c22df7
Version: 1
Effective Time: 20190521
 
SKIN COACH SL.