S.O.S. INSTANT RESCUE- dimethicone gel 
NATURA BISSÉ INTERNATIONAL, S.A.

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.

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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

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)

Revised: 3/2016
Document Id: 2e0932e9-d883-525a-e054-00144ff88e88
Set id: 2cea5bb8-9683-6957-e054-00144ff8d46c
Version: 7
Effective Time: 20160314
 
NATURA BISSÉ INTERNATIONAL, S.A.