ASEPXIA OIL-FREE ACNE BAR- salicylic acid soap

Asepxia Oil-Free Acne Bar by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredient

Salicylic Acid, 2%

Purpose

Acne treatment

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

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.

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

• 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.

Other information

• Store at room temperature

Inactive ingredients

Sodium palmate, Sodium cocoate and/or Sodium palm kernelate, Water, Glycerin, Sodium chloride, Sulfur, Fragrance, Sodium hydroxide, Tetrasodium EDTA, Pentasodium pentetate, Glycolic acid, Titanium dioxide, Salix alba (White Willow) bark extract, BHT, FD&C Yellow 5, Citric Acid, Disodium EDTA, Opuntia Ficus-Indica (Cactus) stem extract, FD&C Yellow 6, Iron Oxide

QUESTIONS

For more product information, please call Toll Free: 1 877 99 GENOM (43666)

SPL UNCLASSIFIED SECTION

Distributed by: Genomma Lab USA Inc., Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 113 g Bar Carton

NEW
FORMULA

OILY SKIN WITH IMPERFECTIONS

Asepxia ®
WITH HYDRO-FORCE™
Acne Bar Soap

Oil-Free
DEEP CLEANSING ANTI-SEBUM

2% Salicylic Acid
Enriched with a touch of sulfur*

> Oil skin control

> Deeply cleans and exfoliates without overdrying

Net Wt. 4 oz (113 g)

INGREDIENTS AND APPEARANCE

ASEPXIA OIL-FREE ACNE BAR 
salicylic acid soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-803
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM COCOATE (UNII: R1TQH25F4I)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SULFUR (UNII: 70FD1KFU70)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE SODIUM (UNII: MP1J8420LU)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
GLYCOLIC ACID (UNII: 0WT12SX38S)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code	Asepxia
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-803-01	1 in 1 CARTON	03/19/2020
1		113 g 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	03/19/2020

Labeler - Genomma Lab USA (832323534)