ASEPXIA ACNE TREATMENT- salicylic acid cream

Asepxia Acne Treatment by

Drug Labeling and Warnings

Asepxia Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicilic Acid 2%

Purpose

Acne Treatment

Uses

• for the treatment of acne
• dries and clears acne blemishes
• penetrates pores to eliminate most acne blemishes
• helps prevent new acne blemishes

Warnings

For external use only

When using this product

• skin irritation and dryness is more likely to occur if you use another acne medication at the same time. If irritation occurs, use only one topical acne med cation at a time

Keep out of reach of children

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

Directions

• clean 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
• If irritation or sensitivity develops, stop use and ask a doctor

Sensitivity test for new user

• apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above

Other information

• Keep tightly closed
• Store at room temperature

Inactive ingredients

Acrylamide Sodium Acrylate Copolymer, Cyclopentasiloxane, Ethylhexylglycerin, Glycerin, Paraffinum Liquid, Phenoxyethanol, Polysorbate 20, Propylene glycol, Sodium Citrate, Trideceth-6, Water.

Questions or comments?

1 877 994 3666. Monday to Friday, 8am to 6pm, Central time.

SPL UNCLASSIFIED SECTION

Distributed by: Genomma Lab USA Inc., Houston, TX 77098

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Asepxia®

ACNE TREATMENT CREAM

2 % SALICYLIC ACID

ELIMINATES MOST PIMPLES AND BLACKHEADS

NET WT.
1 OZ (28 g)

INGREDIENTS AND APPEARANCE

ASEPXIA ACNE TREATMENT 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-064
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 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-064-01	1 in 1 CARTON	09/05/2024
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/05/2024

Labeler - Genomma Lab USA (832323534)