ASEPXIA ACNE MEDICATION WIPES- salicylic acid cloth

Asepxia by

Drug Labeling and Warnings

Asepxia by is a Otc medication manufactured, distributed, or labeled by Genomma Labs, Professional Disposables International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic acid 2%

Purpose

Acne medication

Use

• For the treatment of acne
• Reduces the number of acne pimples and allows skin to heal
• Penetrates pores to clear most acne blemishes
• Helps prevent new acne pimples from forming
• Dries up acne pimples

Warnings

For external use only

When using this product

• skin irritation and dryness may occur if you use another topical acne medication at the same time. If irritations occurs, only use one topical acne medication at a time.
• avoid contact with eyes. If product gets in eyes rinse with water

Stop use and ask a doctor

if excessive skin irritation occurs.

Keep out of reach of children.

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

Directions

• clean skin thoroughly before applying product
• cover entire affected area with a thin layer 1 to 3 times daily
• because excessive drying of skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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. Sensitivitity test for new user Apply product sparingly to 1 or 2 small affected areas during the first 3 days. If no discomfort occurs, follow directions stated above.

Inactive ingredients

Water, Alcohol Denat, Sodium xylenesulfonate, PPG-5-Ceteth-20, PEG-32, Butylene glycol, Phenoxyethanol, Sodium hydroxide, Sodium citrate, Fragrance, Glycerin, Iodopropynyl butylcarbamate, Disodium EDTA, Citrus grandis (grapefruit) fruit extract

Other information

• Close pouch after each use
• Store at room temperature
• Do not flush

SPL UNCLASSIFIED SECTION

Questions or comments 1 877 99 GENOM(43666)

Made in / Hecho en: USA

Distributed by / Distribuido par: Televisa Consumer Products USA, LCC.Houston, TX 77027

Principal Display Panel

Asepxia

2% salicylic acid

2 in 1 acne wipes- cleanses and treats

• clears most pimples & blackheads away
• removes pore-clogging dirt, oil, impurities

7.4 x 7.2 in (18.7 x 18.2 cm)

25wipes

lid:

flow:

INGREDIENTS AND APPEARANCE

ASEPXIA  ACNE MEDICATION WIPES
salicylic acid cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-400
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
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
ALCOHOL (UNII: 3K9958V90M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PEG-32 STEARATE (UNII: 33GX5WQC0M)
GRAPEFRUIT JUICE (UNII: JQ9EK2H6BG)
GLYCERIN (UNII: PDC6A3C0OX)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
GRAPEFRUIT (UNII: O82C39RR8C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-400-01	25 in 1 PACKAGE	07/01/2015
1		6.64 mL in 1 APPLICATOR; 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	07/01/2015

Labeler - Genomma Labs (832323534)

Registrant - Professional Disposables International, Inc. (800777117)

Establishment
Name	Address	ID/FEI	Business Operations
Professional Disposables International, Inc.		800777117	manufacture(50066-400)