Label: MOISTURIZING CREAM- dimethicone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 8, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Dimethicone 4.0%

  • Purpose

    Skin Protectant

  • Uses

    Skin protectant, temporarily protects against harmful Pathogens & Stimuli while moisturizing dry and cracked hands.

  • Warnings

    For external use only

    • When using this product, aviod contact with eyes
    • In case of eye contact, flush with water

    • Keep out of reach of children, except under adult supervision
    • If swallowed, get medical help

    • Discontinue use if skin irritation or redness develops.
  • Directions

    Rub into hands and body until absorbed.

  • Ingredients

    DI Water, Octyl Palmitate, Corn Oil, Dimethicone, Polawax, Grape Seed Oil, Sunflower Butter, Glycerin, Cetyl Alcohol, Geogard Ultra, Triethanolamine 85, Carbopol 941, Aloe Vera, Jojoba, Blue Agave, Cranberry, Strawberry, Raspberry, Pomegranate, Green Tea, Green Coffee Bean, Grape Seed, Blueberry, Acai Berry, Vitamins A, D and E

  • Questions or Comments?

    Call (480) 443-9255 or visit RRlotion.com

  • PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label

    R&R LOTION®
    MOISTURIZING CREAM™

    HAND CREAM

    8 FL. OZ. (236ML) e

    PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    MOISTURIZING CREAM 
    dimethicone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Corn Oil (UNII: 8470G57WFM)  
    Gluconolactone (UNII: WQ29KQ9POT)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Calcium Gluconate (UNII: SQE6VB453K)  
    Carbomer Homopolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: F68VH75CJC)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Grape Seed Oil (UNII: 930MLC8XGG)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    Trolamine (UNII: 9O3K93S3TK)  
    vitamin A (UNII: 81G40H8B0T)  
    cholecalciferol (UNII: 1C6V77QF41)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-801-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34712/21/2015
    Labeler - R & R Lotion, Inc (062979000)
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