RENEW SKIN REPAIR- otc skin protectant drug products cream

RENEW SKIN REPAIR by

Drug Labeling and Warnings

RENEW SKIN REPAIR by is a Otc medication manufactured, distributed, or labeled by Dermarite Industries LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Dimethicone 1.5%

Purpose:

Skin Protectant

Uses:

Temporarily protects and helps relieve chapped or cracked skin. Benificial for face, hands, body, and legs.

Warnings:

• For external use only.
• Avoid contact with eyes. In case of contact, flush thoroughly with water.
• Stop use and ask a doctor if condition worsens or does not improve within 7 days and if symptoms clear up and occur again within a few days.
• Do not use on deep or punctured wounds, animal bites, or serius burns.

Warnings:

• Keep out of reach of children. In case of accidental ingestion contact physician or Poison Control Center right away.

Directions:

Apply cream liberally as needed.

Other Information:

• Store at room temperature (59 o- 86 oF)
• You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

Inactive Infredients:

Water, Olea Europaea(Olive) Oil, Zea Mays (Corn) Oil, Canola Oil, Stearic Acid, glyceryl Stearate, PEG-100 Stearate, Propylene Glycol, Triethanolamine, Aloe Barbadensis Leaf Juice, Glycerin, Butylparaben, Ethylparaben, Isobutylparaben, methylparaben, Phenoxyethanol, propylparaben, Citrus Aurantium Dulcis (orange) Peel Oil, Anthemis Nobilis Flower Oil, Lavandula Officinalis (lavender) Oil, Fragrance, Cetearyl Alcohol, Carbomer, Ascorbyl Palmitate, Disodium EDTA, Tocopheryl Acetate, Niacinamide, Retinyl Palmitate, Cholecalciferol, Pyridoxine HCL

Questions?

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

RENEW SKIN REPAIR 
otc skin protectant drug products cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-405
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.015 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CANOLA OIL (UNII: 331KBJ17RK)
CARBOMER 940 (UNII: 4Q93RCW27E)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
METHYLPARABEN (UNII: A2I8C7HI9T)
NIACINAMIDE (UNII: 25X51I8RD4)
OLIVE OIL (UNII: 6UYK2W1W1E)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
CORN OIL (UNII: 8470G57WFM)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-405-27	793 g in 1 BAG; Type 0: Not a Combination Product	03/03/2011
2	NDC: 61924-405-04	113 g in 1 TUBE; Type 0: Not a Combination Product	03/03/2011
3	NDC: 61924-405-32	907 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/03/2011
4	NDC: 61924-405-05	5 g in 1 PACKET; Type 0: Not a Combination Product	03/03/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/03/2011

Labeler - Dermarite Industries LLC (883925562)

Registrant - Dermarite Industries LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
Dermarite Industries LLC		883925562	manufacture(61924-405)