SANATIVA DRY SKIN RELIEF- petrolatum, dimethicone cream

SANATIVA DRY SKIN RELIEF by

Drug Labeling and Warnings

SANATIVA DRY SKIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Crossover Telecom, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredient:

Petrolatum 30.00%

Dimethicone 3.00%

Skin protectant

Indications:

• Helps relieve, prevent and temporarily protect chafed, chapped, cracked or wind burned skin.
• Temporarily protects minor burns, cuts and scrapes.
• Helps protect skin from the drying effects of wind and cold weather.

Warnings:

• For external use only.
• Avoid contact with eyes.
• If symptoms persist for more than seven days, discontinue use and consult physician.

Do not use

• on deep or puncture wounds, on animal bites or on serious burns.

Keep out of reach of children.

If swallowed, consult physician.

Directions:

• Apply generously to affected area as need

Additional Information:

Store at room temperature.

Inactive Ingredients:

Allantoin, Aqua (Deionized Water), Butylene Glycol, Carbomer, Ceramide NG, Cetearyl Alcohol, Cetearyl lucoside Cetearyl Olivate, Cetyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Collagen, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Phenoxyethanol, Polysorbate-20, Retinyl Palmitate (Vitamin A), Simmondsia Chinensis (Jojoba) Oil, Sodium Ascorbyl Phosphate (Vitamin C), Sorbitan Olivate, Tocopheryl Acetate (Vitamin E)

Package Labeling:

INGREDIENTS AND APPEARANCE

SANATIVA DRY SKIN RELIEF 
petrolatum, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70724-844
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	300 mg  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CERAMIDE NG (UNII: C04977SRJ5)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SORBITAN OLIVATE (UNII: MDL271E3GR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70724-844-01	1 in 1 BOX	09/07/2017
1		60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/07/2017

Labeler - Crossover Telecom, LLC (026911787)