RENEW DIMETHICONE SKIN PROTECTANT- skin protectant cream

Renew Dimethicone Skin Protectant by

Drug Labeling and Warnings

Renew Dimethicone Skin Protectant 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 5%

Purpose:

Skin Protectant

Uses:

• Forms a moisture barrier that prevents and helps treat effects associated with diaper rash from wetness, urine, or stool.
• Temporarily protects and helps relieve chapped or cracked skin.

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.
• Do not use on deep or punctured wounds.

Warnings:

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

Directions:

Clean skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply as necessary. If applying to perineal area, apply after each incontinent episode or diaper change to promote comfort and long lasting protection.

Other Information:

Store at room temperature (59 o- 86 oF)

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Aluminum Stearate, Cera Alba, Cholecalciferol, Chloroxylenol, Corn Oil, Imidiazolidinyl Urea, Dicocoyl Pentaerythrityl Distearyl Citrate, Fragrance, Lanolin, Methylparaben, Mineral Oil, Paraffin wax, Petrolatum, Phenoxyethanol, Propylene Glycol, Propylparaben, Retinyl Palmitate, Sorbitan Sesquioleate, Tocopheryl Acetate, Water.

Questions?

Call 1-800-37-6296

Renew Skin Protectant Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

RENEW DIMETHICONE SKIN PROTECTANT 
skin protectant cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-410
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.05 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: 61924-410-05	5 g in 1 PACKET; Type 0: Not a Combination Product	03/15/2012
2	NDC: 61924-410-04	113 g in 1 TUBE; Type 0: Not a Combination Product	03/15/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/15/2012

Labeler - Dermarite Industries LLC (883925562)

Registrant - Dermarite Industries LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
Dermarite Industries LLC		883925562	manufacture(61924-410)