Skincoach CLEAN by SKIN COACH SL. / Topiderm Inc. II

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]

SKINCOACH CLEAN- salicylic acid liquid 
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.

----------

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 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 a directed by a physician If bothersome dryness occurs, reduce application to once a day or every other day.

Inactive ingredients

Cocamidopropyl Betaine, Disodium EDTA, Fragrance, Glycolic Acid, Linoleamidopropyl PG-Dimonium Chloride Phosphate, PEG-150 Distearate, Polysorbate-20, propylene glycol, Purified water, Red #40 [CI-16035], Sodium C12-15 Pareth-15 sulfonate, Sodium C14-16 Olefin Sulfonate, olefin sulfonate, Triethanolamine, Yellow #5 [CI-19140].

Principal display panel

SKINCOACH CLEAN 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73047-001
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
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)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
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)
SODIUM C12-14 OLEFIN SULFONATE (UNII: 7I962MCQ71)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73047-001-01	200 mL in 1 TUBE; Type 0: Not a Combination Product	05/21/2019	08/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/21/2019	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(73047-001)

Revised: 8/2019

Document Id: bbf70d3a-4e54-42bf-96a8-31ebc0c3ff19

34390-5

Set id: 3c497d59-1a7e-4858-8c97-a029fa2cd77e

Version: 2

Effective Time: 20190806

 

SKIN COACH SL.