Medichoice Barrier Cream

Medichoice Barrier Cream
SPL v2
SPL
SPL Set ID 42477582-3ffa-4e51-a29b-86da07b14382
Route
TOPICAL
Published
Effective Date 2024-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (32 mg)
Inactive Ingredients
Water Glycerin Cetostearyl Alcohol Ppg-15 Stearyl Ether Glyceryl Monostearate Peg-100 Stearate Phenoxyethanol Aloe Vera Leaf Caprylyl Glycol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-25

Description

Dimethicone 3.2%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Dimethicone 3.2%

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.

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. • Reseal label between uses.

Drug Facts

Active Ingredient

Dimethicone 3.2%

Package Labeling:

Inactive Ingredients

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

If Heating Is Desired:

• Peel open label without completely removing it, heat entire package in microwave for no longer than 45 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.

Keep Out of Reach of Children

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

Stop Use and Consult A Doctor

if condition worsens or does not improve within 7 days.


Structured Label Content

Uses

• Temporarily protects and helps relieve chapped or cracked skin

• Helps prevent perineal dermatitis • Protects from minor skin irritation associated with perineal dermatitis

Purpose

Skin Protectant

Warnings

For external use only. 

Keep out of eyes, ears and mouth.

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. • Reseal label between uses.

Drug Facts

Active Ingredient (Active ingredient)

Dimethicone 3.2%

Package Labeling:

Inactive Ingredients (Inactive ingredients)

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

If Heating Is Desired: (If heating is desired:)

• Peel open label without completely removing it, heat entire package in microwave for no longer than 45 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.

Keep Out of Reach of Children (Keep out of reach of children)

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

Stop Use and Consult A Doctor (Stop use and consult a doctor)

if condition worsens or does not improve within 7 days.


Advanced Ingredient Data


Raw Label Data

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