EPIELLE EXFOLIATING SCRUB EXFOLIATING SCRUB- salicylic acid cream

Epielle Exfoliating Scrub by

Drug Labeling and Warnings

Epielle Exfoliating Scrub by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Salicylic Acid 2%

Purpose

Acne treatment

INDICATIONS & USAGE

Use

penetrates pores to control acne blemishes and blackheads

WARNINGS

Warnings For external use only. Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

WHEN USING

When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• wet face
• squeeze product into hands
• massage over entire face
• rinse thoroughly
• for optimal results use 2-3 times per week

STORAGE AND HANDLING

Other information

store at room temperature

INACTIVE INGREDIENT

Inactive ingredients water, sodium cocoyl isethionate, glycerin, synthetic wax, glycol disearate, synthetic wax, stearyl alcohol, docamide MEA, PEG-6 caprylic/capric glycerides, sodium hydroxide, acrylates/c 10-30 alkyl acrylate crosspolymer, stearic acid, sodium benzoate, menthol, santhan gum, lavandula angustifolia(lavender) extract, salvia sclarea (clary) extract, hyacinthus orientalis (hyacinth) extract, chamomilla recutita (matricaria) flower/leaf extract, borago officinalis (borage) extract, centaurea cyanus (cornflower) flower extract, butylene glycol, 1,2-hexanediol, ethylhexylglyerin, blue 1 lake, fragrance

PRINCIPAL DISPLAY PANEL

Epielle exfoliating scrub

INGREDIENTS AND APPEARANCE

EPIELLE EXFOLIATING SCRUB  EXFOLIATING SCRUB
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2.8 g  in 141 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
GLYCOL STEARATE (UNII: 0324G66D0E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
COCAMIDE (UNII: 3YXD33R71G)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHOL (UNII: L7T10EIP3A)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0403-5	141 g in 1 TUBE; Type 0: Not a Combination Product	05/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/31/2018

Labeler - Kareway Product, Inc. (121840057)