Stop-Akneik by FRIDDA DORSCH SL / FRDDA DORSCH

Stop-Akneik by

Drug Labeling and Warnings

Stop-Akneik by is a Otc medication manufactured, distributed, or labeled by FRIDDA DORSCH SL, FRDDA DORSCH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STOP-AKNEIK- niacinamide, salicylic acid, zinc pca gel 
FRIDDA DORSCH 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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Directions

Directions

Apply daily, morning and evening, to clean dry face. For faster results apply an extra dose at night time directly into the spot.

Warnings

Warnings

• For external use only

Inactive ingredients

Inactive ingredients

Water, Alcohol Denat*, Propanediol, Carbomer, Aloe Barbadensis Leaf Extract*, Arginine*, Hydrolized Soy Protein*, Aesculus Hippocastanum Seed Extract*, Glycyrrhiza Glaba Root Extract*, Caprylyl/Capryl Glucoside*. Sodiuym Phytate*, Panthenol, Niacinamide, Zinc PCA*, Allantion, Biotin, Caffine, Aianine, Creatine, Glycerin*, Glycine, Urea, Magnesium Asparate, Saccharide Hydrolysate*, Lactic Acid*, Malic Acid*, Citric Acid*, Glycolic Acid*, Ascorbic Acid*, Tartaric Acid*, Gluconic Acid*, Parfum, Sodium Hydroxide, Sorbic Acid, Benzoic Acid, Sodium Benzonate, Potassium Sorbate, Benzyl Alchol.

(*) Natural/Vegetal Origin

Usage

Usage

• for the treatment of acne

Exfoliating Action:

Helps remove dead cells and excess oil avoiding blackhead formation

Sebo-regulation Action:

Minimizes sebaceous secretions and greasy skin, keeping pores closed

Moisturizing Action:

Helps recover skin's natural moisture

Repairing Action:

Helps regenerate skin marks and dark spots caused by acne

Keep Out of Reach of Children

Keep Out of Reach of Children

• If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Purpose

• Acne medication

Active ingredient

Active ingredient

Salicylic Acid 1.10%

STOP-AKNEIK 
niacinamide, salicylic acid, zinc pca gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72597-2021
Route of Administration	CUTANEOUS, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.572 mg  in 50000 mg

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
NIACINAMIDE (UNII: 25X51I8RD4)	2.6 mg  in 50000 mg
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
PYRROLIDONE CARBOXYLIC ACID (UNII: 6VT1YZM21H)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ARGININE (UNII: 94ZLA3W45F)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
PROPANEDIOL (UNII: 5965N8W85T)
ZINC (UNII: J41CSQ7QDS)	0.052 mg  in 50000 mg
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72597-2021-0	5000 mg in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	01/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/20/2021	05/24/2021

Labeler - FRIDDA DORSCH SL (474018686)

Registrant - FRIDDA DORSCH SL (474018686)

Establishment
Name	Address	ID/FEI	Business Operations
FRDDA DORSCH		474018686	manufacture(72597-2021)

Revised: 5/2021

Document Id: c353217a-2c8d-93ff-e053-2a95a90ad25f

34390-5

Set id: b9477819-f73c-4d29-e053-2a95a90a34be

Version: 3

Effective Time: 20210527