MEDICHOICE BARRIER- dimethicone cloth

MediChoice Barrier by

Drug Labeling and Warnings

MediChoice Barrier by is a Otc medication manufactured, distributed, or labeled by Owens & Minor Distribution, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Dimethicone 3.2%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve chapped or cracked skin
Helps prevent perineal dermatitis Protects from minor skin irritation associated with perineal dermatitis

Warnings

For external use only.
Keep out of eyes, ears and mouth.

Stop use and consult a doctor

if condition worsens or does not improve within 7 days.

Keep out of reach of children

except with adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Remove wet and soiled garment. Cleanse soiled area using a fresh barrier cream cloth. Discard wipe after use. Do not flush.  For individual use only.

If heating is desired:

Tear open package, heat entire package in microwave for no longer than 18 seconds. Check the temperature of cloths as microwave wattage varies. May also used at room temperature. Ensure temperature of washcloths is not excessively hot. Gloves diminish sensitivity to heat. Closely monitor heat level with infants, unresponsive or skin sensitive individuals.

Inactive ingredients

Aqua, Glycerin, Cetearyl Alcohol, PPG-15 Stearyl Ether, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Capryly Glycol, Xanthan Gum

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

MEDICHOICE BARRIER 
dimethicone cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39892-0950
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	32 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39892-0950-1	3 in 1 PACKAGE	01/25/2024
1		20 g in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 39892-0950-2	72 in 1 CASE	01/25/2024
2		216 in 1 PACKAGE
2		20 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	01/25/2024

Labeler - Owens & Minor Distribution, Inc. (847412269)