S.O.S. INSTANT RESCUE (DIMETHICONE) GEL [NATURA BISSÉ INTERNATIONAL, S.A.]

S.O.S. INSTANT RESCUE (DIMETHICONE) GEL [NATURA BISSÉ INTERNATIONAL, S.A.]
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NDC 63730-391-01, 63730-391-02, 63730-391-03, 63730-391-04, 63730-391-05, 63730-391-06
Set ID 2cea5bb8-9683-6957-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager NATURA BISSÉ INTERNATIONAL, S.A.
Generic Name
Product Class
Product Number
Application Number PART347
  • PURPOSE

    Skin Protectant

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  • 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

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  • ACTIVE INGREDIENT

    Dimethicone ........1%

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  • DOSAGE AND ADMINISTRATION

    Apply as needed

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  • 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.

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

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

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  • 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.

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  • OTHER INFORMATION

    Protect this product from excessive heat and direct sun.

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  • PACKAGE LABEL
  • INGREDIENTS AND APPEARANCE
    S.O.S. INSTANT RESCUE 
    dimethicone gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63730-391
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1 mg  in 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63730-391-01 30 mg in 1 JAR; Type 0: Not a Combination Product 02/29/2016 03/14/2016
    2 NDC:63730-391-02 2 mg in 1 JAR; Type 0: Not a Combination Product 02/29/2016 03/14/2016
    3 NDC:63730-391-03 7 mg in 1 JAR; Type 0: Not a Combination Product 02/29/2016 03/14/2016
    4 NDC:63730-391-04 30 mg in 1 TUBE; Type 0: Not a Combination Product 03/14/2016
    5 NDC:63730-391-05 2 mg in 1 TUBE; Type 0: Not a Combination Product 03/14/2016
    6 NDC:63730-391-06 7 mg in 1 TUBE; Type 0: Not a Combination Product 03/14/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 02/29/2016
    Labeler - NATURA BISSÉ INTERNATIONAL, S.A. (464431576)
    Establishment
    Name Address ID/FEI Business Operations
    NATURA BISSÉ INTERNATIONAL, S.A. 464431576 manufacture(63730-391)
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