ASEPXIA FACIAL WASH ACNE CLEANSER ACNE MEDICATION- sulfur lotion

Asepxia Facial Wash Acne Cleanser by

Drug Labeling and Warnings

Asepxia Facial Wash Acne Cleanser by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA Inc., Garcoa, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Sulfur 3%

Purpose

Acne Medication

Uses

• ♦ For the treatment of Acne
• ♦ Reduces the number of acne pimples
• ♦ Allows skin to heal
• ♦ Penetrates pores to clear most acne blemishes
• ♦ Dries up acne pimples
• ♦ Helps keep skin clear of new acne blemishes, acne pimples, whiteheads and blackheads

Warnings

For external use only

Do not use on

• ♦ broken skin
• ♦ large areas of skin

When using this product

• ♦ skin irritation and dryness may occur if you use other topical acne medications at the same time or immediately following use of this product. If this occurs, use only one medication at a time unless directed by a doctor
• ♦ avoid contact with eyes. If product gets in eyes rinse with water
• ♦ apply only to areas of acne

Stop use and ask a doctor if excessive skin irritation occurs

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• ♦ Use daily on skin with acne
• ♦ For best results, apply liberally over wet skin with a clean wash cloth or body puff, concentrating on areas prone to acne
• ♦ Rinse thoroughly and pat dry with a clean towel
• ♦ If bothersome dryness or peeling occurs, reduce application to every other day
• ♦ Do not apply close to the eyes

Other information

• ♦ Store at room temperature

Inactive ingredients

Water, Sodium C14-16 olefin sulfonate, Cocamidopropyl betaine, Acrylates copolymer, Glycerin, Polyquaternium-7, Polysorbate 20, Fragrance, Phenoxyethanol, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Chloride

Questions or comments?

1 877 99 GENOM (43666)

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Distributed by:
Televisa Consumer Products USA, LLC.
Houston, TX, 77027

PRINCIPAL DISPLAY PANEL - 250 ml Bottle Label

Asepxia®

Sulfur 3%

FACIAL WASH
ACNE CLEANSER

DEEP CLEANSING

Fast acting

Helps keep pores unblocked
for clearer skin everyday

05-3315

Genomma Lab.®
8.45 FL. OZ
(250 ml)

INGREDIENTS AND APPEARANCE

ASEPXIA FACIAL WASH ACNE CLEANSER   ACNE MEDICATION
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Glycerin (UNII: PDC6A3C0OX)
Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 MW) (UNII: 0L414VCS5Y)
Polysorbate 20 (UNII: 7T1F30V5YH)
Phenoxyethanol (UNII: HIE492ZZ3T)
Edetate Disodium (UNII: 7FLD91C86K)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)
Sodium Chloride (UNII: 451W47IQ8X)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-051-01	250 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	05/13/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	05/13/2015

Labeler - Genomma Lab USA Inc. (832323534)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc.		036464697	MANUFACTURE(50066-051)