StrataClear by Stratpharma AG StrataClear

StrataClear by

Drug Labeling and Warnings

StrataClear by is a Otc medication manufactured, distributed, or labeled by Stratpharma AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STRATACLEAR- salicylic acid gel 
Stratpharma AG

----------

StrataClear

DRUG FACTS

Active Ingredient

Salicylic Acid  2%

Purpose

Acne Treatment

Uses

• treats acne
• helps prevent new acne
• dries up acne

Warnings

For external use only

Do not use

• on broken skin
• if pregnant or lactating

When using this product

• avoid unnecessary sun exposure and use a sunscreen
• do not use in or near eyes
• note that using other topical acne drugs at the same time or right after use of this product may increase dryness or skin irritation.

Stop use and ask a doctor if

too much skin irritation or sensitivity develops or increases.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• gently massage cleanser onto skin and remove with lukewarm water.
• use once daily, alternating use with another, non-drug cleanser
• if bothersome dryness or peeling occurs, reduce application to every other day.  

Other information

store at 19-24 ºC (66-75 ºF)

Inactive ingredients:  Water (Aqua), Sorbitol, Ammonium Lauryl Sulfate, Cetyl Alcohol, Stearyl Alcohol, PPG-12/SMDI Copolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil 

STRATACLEAR 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73661-458
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TEA TREE OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73661-458-20	20 mL in 1 PACKAGE; Type 0: Not a Combination Product	05/16/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	05/16/2022	08/01/2022

Labeler - Stratpharma AG (483232695)

Revised: 12/2023

Document Id: 0bc7f6c8-8141-9292-e063-6294a90a2bfb

34390-5

Set id: 752c31e1-d21c-45a2-8d91-141d842d0c41

Version: 2

Effective Time: 20231205