Label: S.O.S. INSTANT RESCUE- dimethicone gel

  • 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 March 14, 2016

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  • PURPOSE

    Skin Protectant

  • INDICATIONS AND USAGE


    Helps prevent, temporarily protects and helps relieve chapped or cracked skin.
    Helps prevent and protect from the drying effects of wind and cold weather

  • ACTIVE INGREDIENT

    Dimethicone ........1%

  • DOSAGE AND ADMINISTRATION

    Apply as needed

  • INACTIVE INGREDIENTS

    Water, Pentylene Glycol, Calendula Officinalis Flower Extract, Methyl Gluceth-10,
    Propylene Glycol, Butylene Glycol, Aloe Barbadensis Leaf Extract, Sodium Acrylates
    Copolymer, Panthenol, Allantoin, Lecithin, Glycerin, Arginine, Laureth-3, Arnica
    Montana Flower Extract, Hydroxyethylcellulose, Propolis Extract, Disodium EDTA,
    Potassium Sorbate, Acetyl Dipeptide-1 Cetyl Ester, Urea, Lactic Acid, Sodium Lactate,
    Serine, Sorbitol, Pseudoalteromonas Ferment Extract, Sodium Benzoate, Hydrolyzed
    Wheat Protein, Sodium Chloride, Hydrolyzed Soy Protein, Ascorbic Acid, Phenoxyethanol,
    Caprylyl Glycol, Xanthan Gum, Citric Acid, Tripeptide-10 Citrulline, Carbomer,
    Tripeptide-1, Triethanolamine.

  • WARNINGS

    For external use only
    When using this product - do not get into eyes.
    Do not use on deep or puncture wounds - animal bites - serious burns.

  • KEEP OUT OF REACH OF CHILDREN

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

  • STOP USE

    Stop Use and Ask Doctor if conditions worsens - symptoms last more than 7 days or clear up and occur again
    within a few days.

  • OTHER INFORMATION

    Protect this product from excessive heat and direct sun.

  • PACKAGE LABEL

    LABEL 4LABEL 3LABEL 2LABEL 1

  • INGREDIENTS AND APPEARANCE
    S.O.S. INSTANT RESCUE 
    dimethicone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63730-391
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA (UNII: 0214C2T14J)  
    LACTIC ACID, D- (UNII: 3Q6M5SET7W)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    ALTEROMONAS MACLEODII (UNII: BPX036043D)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRIPEPTIDE-10 CITRULLINE (UNII: 2732R0E76W)  
    PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H)  
    ALLANTOIN, (+)- (UNII: XDK458E1J9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARGININE, D- (UNII: R54Z304Z7C)  
    LAURETH-3 (UNII: F32E4CB0UJ)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CETYL HYDROXYETHYLCELLULOSE (550000 MW) (UNII: 2MIM45ZIL3)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    N-ACETYL DIPEPTIDE-1 (UNII: HA41Z1UF8D)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL, L- (UNII: 01Q0586BG1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    SERINE, D- (UNII: 1K77H2Z9B1)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EGTA DISODIUM (UNII: 7T6F42A6GN)  
    METHYL GLUCETH-10 (UNII: N0MWT4C7WH)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63730-391-0130 mg in 1 JAR; Type 0: Not a Combination Product02/29/201603/14/2016
    2NDC:63730-391-022 mg in 1 JAR; Type 0: Not a Combination Product02/29/201603/14/2016
    3NDC:63730-391-037 mg in 1 JAR; Type 0: Not a Combination Product02/29/201603/14/2016
    4NDC:63730-391-0430 mg in 1 TUBE; Type 0: Not a Combination Product03/14/2016
    5NDC:63730-391-052 mg in 1 TUBE; Type 0: Not a Combination Product03/14/2016
    6NDC:63730-391-067 mg in 1 TUBE; Type 0: Not a Combination Product03/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/29/2016
    Labeler - NATURA BISSÉ INTERNATIONAL, S.A. (464431576)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURA BISSÉ INTERNATIONAL, S.A.464431576manufacture(63730-391)
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