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

Keep out of reach of children

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

Directions

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

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
Document Id: 7871f3de-387b-7df3-e053-2a91aa0ad156
Set id: 26020825-0795-098e-e054-00144ff8d46c
Version: 3
Effective Time: 20181017
 
PREP Cosmetics LLC