Label: RENUEE- dimethicone cream

  • 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 July 29, 2014

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  • Active Ingredient

    Dimethicone 2%

  • Purpose

    Skin protectant

  • Use

    ■ helps prevent, temporarily protects and relieve chafed, chapped, or cracked skin

  • Warnings

    For external use only

  • When using this product

    ■ do not get into eyes

  • Stop use and ask a doctor if

    ■ condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

  • Do not use on

    ■ deep or puncture wounds ■ animal bites ■ serious burns

  • If pregnant or breast feeding

    ask a health professional before use

  • Keep out of reach of children

    to avoid accidental poisoning, in case of accidental ingestion contact a doctor or Poison Control Center immediately.

  • Directions

    apply as needed

  • Inactive Ingredients

    Deionized Water, Aloe Vera (Aloe Barbadensis) Leaf Gel, Gotu Kola (Centella Asiatica) Extract, Seaweed (Fucus Vesiculosus) Extract, Ginkgo biloba, Shea (Butyrospermum Parkii) Butter, Cocoa (Theobroma Cacao) Butter, Caffeine, Sweet Almond (Prunus Amygdalus Dulcis) Oil, Xanthan Gum, Tetrasodium EDTA, Elderberry (Sambucus Nigra) Extract, Jojoba Esters, Glycerin, Green Tea (Camellia Sinensis) Leaf Extract, Horsetail (Equisetum Arvense) Extract, Hydrolyzed Wheat Proteins, Tocopheryl Acetate (Vitamin E), Acrylates Copolymer, Propylene Glycol, SD-Alcohol 40B, Triethanolamine, Fragrance, DMDM Hydantoin, Caramel Color, D&C Orange #4, FD&C Yellow #5

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    RENUEE 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68973-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    GINKGO BILOBA WHOLE (UNII: 660486U6OI)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    D&C ORANGE NO. 11 (UNII: B16H36W4W4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68973-002-9090 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/15/2014
    Labeler - PMC TRADE, EXPORT AND IMPORT (179635003)
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