PREP EVERYDAY CLEAR ACNE- salicylic acid acne treatment solution

PREP Everyday Clear Acne by

Drug Labeling and Warnings

PREP Everyday Clear Acne by is a Otc medication manufactured, distributed, or labeled by PREP Cosmetics LLC, Richard Hamer Associates LLC, Taka USA, Inc dba Cosmetic Innovations. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Salicylic acid 1%

Purpose

Acne medication

Use

For the treatment of acne

Warnings

• For external use only.

• When using this product: Skin irritation or dryness is more likely to occur if you use another topicl acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• Rinse right away with water if it gets in the eyes.

Keep out of reach of children

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

Directions

• Clean the skin thoroughy before applying the product.
• Cover the entire affected area with a thin layer one to three times daily.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.

Sensitivity Test for a New User

Apply product sparingly to one or two small affected areas during the first three days. If no discomfort occurs, follow the directions stated elsewhere on this label.

INACTIVE INGREDIENT

Azelaic Acid, Butylene Glycol, Chamaemelum Nobile Flower Oil, Ethylhexylglycerin, Geranium Maculatum Root Oil, Hydroxyethyl Cellulose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxypropyl Distarch Phosphate, High Amylose Corn, Lavender Oil, Mandelic Acid, PEG-12 Glyceryl Dimyristate, PEG-23 Glyceryl Distearate, Phytate Sodium, Polysorbate 60, Potassium Sorbate, Propanediol, Rosa Canina Fruit, Salix Nigra Bark, Sorbitol, Squalane, Water

Other Information

• Store at room temperature

Questions?

Call toll free 1-800-401-6031

www.prepyourskin.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREP EVERYDAY CLEAR ACNE 
salicylic acid acne treatment solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70231-0017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
PHYTATE SODIUM (UNII: 88496G1ERL)
GERANIUM MACULATUM ROOT OIL (UNII: H2E371EDYX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
LAVENDER OIL (UNII: ZBP1YXW0H8)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
PEG-12 GLYCERYL DIMYRISTATE (UNII: VS4W16AQ3X)
SALIX NIGRA BARK (UNII: QU52J3A5B3)
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
PEG-23 GLYCERYL DISTEARATE (UNII: 527412VE0U)
SORBITOL (UNII: 506T60A25R)
HYDROXYETHYL CELLULOSE (4000 CPS AT 1%) (UNII: ZYD53NBL45)
MANDELIC ACID (UNII: NH496X0UJX)
AZELAIC ACID (UNII: F2VW3D43YT)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SQUALANE (UNII: GW89575KF9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70231-0017-1	1 in 1 CARTON	11/06/2015
1		30 mL in 1 BOTTLE; 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	11/06/2015

Labeler - PREP Cosmetics LLC (053793815)

Registrant - Richard Hamer Associates LLC (067731889)

Establishment
Name	Address	ID/FEI	Business Operations
Taka USA, Inc dba Cosmetic Innovations		802860515	manufacture(70231-0017) , pack(70231-0017)