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

4-N-1 WASH by

Drug Labeling and Warnings

4-N-1 WASH by is a Otc medication manufactured, distributed, or labeled by DermaRite Industries, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-208
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-208-16	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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/02/2010

Labeler - DermaRite Industries, LLC (883925562)

Registrant - DermaRite Industries, LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
DermaRite Industries, LLC		883925562	manufacture(61924-208)