Pore Release 2% Salicylic Acid Acne Treatment

Pore Release 2 Salicylic Acid Acne Treatment by

Drug Labeling and Warnings

Pore Release 2 Salicylic Acid Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Hero Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PORE RELEASE 2 SALICYLIC ACID ACNE TREATMENT- salicylic acid liquid 
Hero Cosmetics, Inc.

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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Pore Release 2% Salicylic Acid Acne Treatment

Drug Facts

Active ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

• For the treatment of acne
• Reduces the number of blackheads
• Helps keep skin clear of new black heads

Warnings

For external use only.

When using this product

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. avoid contact with eyes. If contact occurs, flush thoroughly with water.

Keep out of reach of children.

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

Stop use and ask a doctor if

irritation becomes severe

Sunburn Alert:

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Directions

Cleanse the skin thoroughly before applying this product.  Cover the entire affected area with a thin layer one to three times daily.  Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. 

If bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive ingredients

water/aqua, butylene glycol, gluconolactone, arginine, glycolic acid, aloe barbadensis leaf juice, nelumbo nucifera root water, glycerin, hydrolyzed gardenia florida extract, biosaccharide gum-1, sodium levulinate, glyceryl caprylate, maltodextrin, sodium anisate, sodium hydroxide, potassium sorbate, sodium benzoate, citric acid

Questions or comments?

347-669-0686

Package Labeling:

PORE RELEASE 2 SALICYLIC ACID ACNE TREATMENT 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73381-001
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ARGININE (UNII: 94ZLA3W45F)
GLYCOLIC ACID (UNII: 0WT12SX38S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
NELUMBO NUCIFERA ROOT OIL (UNII: 382005USDH)
GLYCERIN (UNII: PDC6A3C0OX)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SODIUM ANISATE (UNII: F9WFJ28MV9)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73381-001-00	1 in 1 BOX	12/01/2022	11/21/2024
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/01/2022	11/21/2024

Labeler - Hero Cosmetics, Inc. (053668306)

Revised: 12/2022

Document Id: eeda94de-45f9-695e-e053-2a95a90a953b

34390-5

Set id: 4801e7ce-f2b8-4669-ab5c-302e53fadf7e

Version: 2

Effective Time: 20221202