Cracked Heel Balm 1%dimethicone

Cracked Heel Balm 1%dimethicone
SPL v2
SPL
SPL Set ID 42b7c9f8-0557-8e33-e063-6394a90a5919
Route
TOPICAL
Published
Effective Date 2025-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (10 mg)
Inactive Ingredients
Butyrospermum Parkii (shea) Butter Carbomer Phenoxyethanol Cetearyl Alcohol Glycerin Petrolatum Glyceryl Stearate Allantoin Stearic Acid Triethylene Glycol Water Sodium Hydroxide Ceteareth-20 Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-03

Description

Dimethicone 1%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Dimethicone 1%

Uses

■ helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin ■ temporarily protects minor: • cuts • scrapes • burns ■ helps prevent and protect from the drying effects of wind and cold weather

Section 51945-4

Warnings

For external use only

Directions

■ apply generously to affected area as needed

Do Not Use On

■ deep or puncture wounds ■ animal bites ■ serious burns

Active Ingredient

Dimethicone 1%

Inactive Ingredients

allantoin, butyrospermum parkii (shea) butter, carbomer, ceteareth-20, cetearyl alcohol, disodium EDTA, glycerin, glyceryl stearate, phenoxyethanol, petrolatum, sodium hydroxide, stearic acid, triethylene glycol, water

When Using This Product

do not get into eyes

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If:

■ conditon worsens ■ symptoms last more than 7 days or clear up and occur again wihtin a few days


Structured Label Content

Uses

■ helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin ■ temporarily protects minor: • cuts • scrapes • burns ■ helps prevent and protect from the drying effects of wind and cold weather

Section 51945-4 (51945-4)

Purpose

Skin protectant

Warnings

For external use only

Directions

■ apply generously to affected area as needed

Do Not Use On (Do not use on)

■ deep or puncture wounds ■ animal bites ■ serious burns

Active Ingredient (Active ingredient)

Dimethicone 1%

Inactive Ingredients (Inactive ingredients)

allantoin, butyrospermum parkii (shea) butter, carbomer, ceteareth-20, cetearyl alcohol, disodium EDTA, glycerin, glyceryl stearate, phenoxyethanol, petrolatum, sodium hydroxide, stearic acid, triethylene glycol, water

When Using This Product (When using this product)

do not get into eyes

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

■ conditon worsens ■ symptoms last more than 7 days or clear up and occur again wihtin a few days


Advanced Ingredient Data


Raw Label Data

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