63148-028-05, Life Is Healed

63148-028-05, Life Is Healed
SPL v3
SPL
SPL Set ID e31f3fcf-cab7-4e25-8ab2-0d0a4d526faf
Route
TOPICAL
Published
Effective Date 2021-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (12 mg)
Inactive Ingredients
Water Glycerin Petrolatum Distearyldimonium Chloride Isopropyl Palmitate Cetyl Alcohol Oatmeal Sodium Chloride Sodium Hydroxide Ethylhexylglycerin Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-20

Description

Dimethicone (1.2%)

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Dimethicone (1.2%)

Uses

helps prevent and temporarily protects chafed, chapped or cracked skin.

Pdp05

Warnings

For external use only.

Directions

apply as needed.

Active Ingredient.

Dimethicone (1.2%)

Inactive Ingredients

Water (Aqua), Glycerin, Petrolatum, Distearyldimonium Chloride, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Sodium Chloride, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

When Using This Product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Stop Using This Product and Ask A Doctor If

condition worsens or symptoms persist for more than seven days or occur again within a few days.


Structured Label Content

Uses

helps prevent and temporarily protects chafed, chapped or cracked skin.

Pdp05 (PDP05)

Purpose

Skin Protectant

Warnings

For external use only.

Directions

apply as needed.

Active Ingredient.

Dimethicone (1.2%)

Inactive Ingredients

Water (Aqua), Glycerin, Petrolatum, Distearyldimonium Chloride, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Sodium Chloride, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

When Using This Product (When using this product)

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)

condition worsens or symptoms persist for more than seven days or occur again within a few days.


Advanced Ingredient Data


Raw Label Data

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