SKINCOACH TREAT- benzoyl peroxide gel

Skincoach TREAT by

Drug Labeling and Warnings

Skincoach TREAT by is a Otc medication manufactured, distributed, or labeled by SKIN COACH SL., Topiderm Inc. II. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                               Purpose

Benzoyl Peroxide USP 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 REACH OF CHILDREN

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.

DOSAGE & ADMINISTRATION

Principal display panel

INGREDIENTS AND APPEARANCE

SKINCOACH TREAT 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73047-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73047-003-01	57 g in 1 TUBE; Type 0: Not a Combination Product	05/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/21/2019

Labeler - SKIN COACH SL. (468534978)

Registrant - SKIN COACH SL. (468534978)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm Inc. II		078841698	manufacture(73047-003)