PURITY MADE SIMPLE (SALICYLIC ACID) CREAM [PHILOSOPHY, INC.]

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  • PURITY MADE SIMPLE (SALICYLIC ACID) CREAM [PHILOSOPHY, INC.]

PURITY MADE SIMPLE (SALICYLIC ACID) CREAM [PHILOSOPHY, INC.]
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NDC 50184-1060-1, 50184-1060-2
Set ID ed785dc1-a1a2-4e89-a4f7-2d0eef3ca2bb
Category HUMAN OTC DRUG LABEL
Packager Philosophy, Inc.
Generic Name
Product Class
Product Number
Application Number PART333D
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid (0.5%)

  • Purpose

    Acne Treatment

  • Indications

    For the treatment of acne

  • Warnings

    For external use only.

    Using other topical acne medications 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.

  • Directions

    • gently massage onto clean, dry skin focusing on your t-zone and oily areas.
    • leave on skin for 5–10 minutes, or until the clay is completely dry. rinse with warm water.
    • for deeper exfoliation, increase the massage intensity when applying, and while removing with water, perform a second massage.
    • we recommend using two times per week.
    • this product may cause eye irritation. avoid contact with eyes. if contact occurs, flush with plenty of water. if irritation persists, consult a physician.
  • Inactive Ingredients

    water, kaolin, diatomaceous earth, propanediol, bentonite, decyl glucoside, alcohol denat., lauryl glucoside, propylene glycol, polysilicone-11, pvp, xanthan gum, sodium pca, sodium citrate, citric acid, fragrance, chlorphenesin, disodium edta, laureth-12, phenoxyethanol, vanillyl butyl ether, ethylhexylglycerin, titanium dioxide (ci 77891).

  • Questions or Comments?

    Call toll-free 1-800-568-3151 from 9 a.m. - 8 p.m. ET (Monday – Friday)

  • Principal Display Panel - 75 mL Carton Label

    purity
    made simple
    pore extract

    philosophy: no one
    is perfect, but we can
    all be pure. purity is
    intention. purity is
    perspective. purity
    is principle. reserve
    judgment, and treat
    others the way you
    want to be treated.

    exfoliating clay mask
    salicylic acid acne treatment

    75 ml/2.5 fl. oz.

    Figure
  • Principal Display Panel - 75 mL Tube Label

    purity
    made simple
    pore extract

    philosophy: no one
    is perfect, but we can
    all be pure. purity is
    intention. purity is
    perspective. purity
    is principle. reserve
    judgment, and treat
    others the way you
    want to be treated.

    exfoliating clay mask
    salicylic acid acne treatment

    75 ml/2.5 fl. oz.

    Figure
  • INGREDIENTS AND APPEARANCE
    PURITY MADE SIMPLE 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-1060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 ug  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BENTONITE (UNII: A3N5ZCN45C)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ALCOHOL (UNII: 3K9958V90M)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAURETH-12 (UNII: OAH19558U1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-1060-11 in 1 CARTON04/01/2018
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:50184-1060-21 in 1 CARTON04/01/2018
    275 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/01/2018
    Labeler - Philosophy, Inc. (948102256)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies and Packaging Inc.809172885manufacture(50184-1060)
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