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S.O.S. INSTANT RESCUE by NATURA BISSÉ INTERNATIONAL, S.A.

Medically reviewed on Mar 8, 2017

Dosage form: gel
Ingredients: DIMETHICONE 1mg in 100mg
Labeler: NATURA BISSÉ INTERNATIONAL, S.A.
NDC Code: 63730-394

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.

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

S.O.S. INSTANT RESCUE 
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63730-394
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE1 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
BIOTINOYL TRIPEPTIDE-1 
PROPOLIS WAX 
1,3-BIS(BENZOTHIAZOL-2-YLTHIOMETHYL)UREA 
LACTIC ACID, D- 
SODIUM LACTATE 
ALTEROMONAS MACLEODII 
BUTYLENE GLYCOL 
SODIUM BENZOATE 
TRIPEPTIDE-10 CITRULLINE 
PROPYLENE GLYCOL, (R)- 
ALLANTOIN, (+)- 
ALOE VERA LEAF 
ARGININE, D- 
LAURETH-3 
ARNICA MONTANA FLOWER 
CETYL HYDROXYETHYLCELLULOSE (550000 MW) 
POTASSIUM SORBATE 
N-ACETYL DIPEPTIDE-1 
ASCORBIC ACID 
CITRIC ACID ACETATE 
LECITHIN, SUNFLOWER 
GLYCERIN 
SORBITOL, L- 
TROLAMINE 
SODIUM ACRYLATE 
PANTHENOL 
PENTYLENE GLYCOL 
CALENDULA OFFICINALIS FLOWER 
CAPRYLYL GLYCOL 
CARBOMER 940 
WATER 
SERINE, D- 
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) 
PHENOXYETHANOL 
XANTHAN GUM 
EGTA DISODIUM 
METHYL GLUCETH-10 
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) 
Packaging
#Item CodePackage Description
1NDC:63730-394-0130 mg in 1 JAR
2NDC:63730-394-022 mg in 1 JAR
3NDC:63730-394-037 mg in 1 JAR
4NDC:63730-394-0430 mg in 1 TUBE
5NDC:63730-394-052 mg in 1 TUBE
6NDC:63730-394-067 mg in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/08/2017
Labeler - NATURA BISSÉ INTERNATIONAL, S.A. (464431576)
Establishment
NameAddressID/FEIOperations
NATURA BISSÉ INTERNATIONAL, S.A.464431576manufacture(63730-394)

 
NATURA BISSÉ INTERNATIONAL, S.A.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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