ASEPXIA SOFTENING ACNE BAR- salicylic acid soap

Asepxia Softening Acne Bar by

Drug Labeling and Warnings

Asepxia Softening 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, Fragrance, Sodium laureth sulfate, Sodium hydroxide, Sodium chloride, Glycereth-26, Tetrasodium etidronate, Glycolic acid, Mineral oil, Titanium dioxide, Cucumis sativus (Cucumber) fruit extract, Stearic Acid, Cetyl alcohol, Glyceryl stearate, Salix alba (White Willow) bark extract, FD&C Blue 1, Citric acid, Disodium EDTA, Triethanolamine, Opuntia Ficus-Indica (Cactus) stem extract, Carbomer, D&C Red 33, Iron Oxide, Pentasodium pentetate

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

DRY SKIN WITH IMPERFECTIONS

Asepxia®
WITH HYDRO-FORCE®
Acne Bar Soap

Softening
DEEP CLEANSING + MOISTURIZING

2% Salicylic Ácid

Enriched with cucumber extract

> Cleans skin and leaves a soft & fresh feel

> Wash away dirt, oil, bacteria and dead skin cells

Net Wt. 4 oz (113 g)

INGREDIENTS AND APPEARANCE

ASEPXIA SOFTENING ACNE BAR 
salicylic acid soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-805
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
GLYCOLIC ACID (UNII: 0WT12SX38S)
MINERAL OIL (UNII: T5L8T28FGP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CUCUMBER (UNII: YY7C30VXJT)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TROLAMINE (UNII: 9O3K93S3TK)
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM COCOATE (UNII: R1TQH25F4I)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERETH-26 (UNII: NNE56F2N14)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-805-01	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)