PREP EVERYDAY CLEAR ACNE- salicylic acid acne treatment solution 
PREP Cosmetics LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PREP Acne Treatment

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.

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

Carton Label

PREP EVERYDAY CLEAR ACNE 
salicylic acid acne treatment solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70231-0017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70231-0017-11 in 1 CARTON11/06/2015
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/06/2015
Labeler - PREP Cosmetics LLC (053793815)
Registrant - Richard Hamer Associates LLC (067731889)
Establishment
NameAddressID/FEIBusiness Operations
Taka USA, Inc dba Cosmetic Innovations802860515manufacture(70231-0017) , pack(70231-0017)

Revised: 10/2018
 
PREP Cosmetics LLC