4-N-1 Wash (Otc Skin Protectant Drug Product) Cream [Dermarite Industries, Llc] -

4-N-1 WASH (OTC SKIN PROTECTANT DRUG PRODUCT) CREAM [DERMARITE INDUSTRIES, LLC]
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Active Ingredients:

Dimethicone 1%
Purpose:

Skin Protectant
Uses:
- A gentle alternative to soap and water.
- Cleans, restores, nourishes, and protects even most delicate skin.
- Ideal for frequent cleansing and incontinence care.
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; symptoms clear up and occur again within a few days.
- Do not use on deep puncture wounds, animal bites, or serious burns.
Warnings:
- Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.
Directions:
- For skin care: Apply quarter-sized amount to warm, damp cloth. Wash skin, turning the cloth as the skin is cleansed to remove residue.
- For incontinence care: Remove excess fecal matter. Follow skin care directions above
Other Information:

Store at room temperature (59°-86°F)
Ingredients:

Butylparaben, Ceteareth-20, Cetearyl Alcohol, Cetearyl Isononanoate, Cetyl Palmitate, Ehtylparaben, Fragrance, Glyceryl Stearate, Isobutylparaben, Methyl paraben, PEG-100 Stearate, PEG-20 Glyceryl Stearate, Phenoxyethanol, Propylparaben, Water
4-N-1 Wash Cream Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

4-N-1 WASH
otc skin protectant drug product cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.01 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-20 GLYCERYL STEARATE (UNII: MJV0165YY8)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61924-208-16	452 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/02/2010
2	NDC:61924-208-04	113 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2010