SKINCOACH CLEAN- salicylic acid liquid

Skincoach CLEAN by

Drug Labeling and Warnings

Skincoach CLEAN 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

Salicylic Acid USP 2%------------ Acne medication

Uses

Skin cleanser for the treatment of acne.

Warnings

For external use only

Keep away from eyes, lips, and mouth.

Using other topical medications, while using this product or immediately thereafter, may increase dryness or irritation. If this occurs discontinue use and see your doctor. 

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of childen. If swallowed, get medical help or contact a Poison Control Center.

Sunscreen use is recommended with any glycolic acid product and for an additional week thereafter because some individuals may be more sensitive to sunlight.

Directions

Wet affected area, apply, and rinse well. Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician If bothersome dryness occurs, reduce application to once a day or every other day.

DOSAGE & ADMINISTRATION

Inactive ingredients

Camellia sinensis (Green Tea) Polyphenols, Cocamidopropyl Betaine, Disodium EDTA, Fragrance, Glycolic Acid, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Polysorbate-20, Purified Water, Red #40 [CI-16035], Sodium C12-15 Pareth-15 Sulfonate, Sodium C14-16 Olefin Sulfonate,  Triethanolamine, Yellow #5 [CI-19140], Zinc PCA.

Principal display panel

INGREDIENTS AND APPEARANCE

SKINCOACH CLEAN 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73047-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 46000 MW) (UNII: LQ35R50VR1)
LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM C12-15 PARETH-15 SULFONATE (UNII: 353VA59XH8)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ZINC PIDOLATE (UNII: C32PQ86DH4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73047-004-01	200 mL in 1 TUBE; Type 0: Not a Combination Product	08/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/07/2019

Labeler - SKIN COACH SL. (468534978)

Registrant - SKIN COACH SL. (468534978)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm Inc. II		078841698	manufacture(73047-004)