Gl Health Barrier Skin Protectant

Gl Health Barrier Skin Protectant
SPL v2
SPL
SPL Set ID 76cfa330-fea9-48d4-b187-469154765d39
Route
TOPICAL
Published
Effective Date 2022-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (205 mg)
Inactive Ingredients
Aloe Yellow Wax Shea Butter Helianthus Annuus Flowering Top .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-16

Description

Zinc Oxide 20.5%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 20.5%

Uses

• Helps treat and prevent diaper rash • Protects chafed skin due to wetness and helps seal out wetness

Warnings

For external use only

Directions

Apply a layer of Barrier® to skin area you wish to protect. Change wet & spoiled diapers immediately. Clean the diaper area & allow to dry. Apply cream liberally & as often as necessary with each diaper change, especially at bedtime or anytime when exposed to wet diapers for a long period of time.

Questions?

Call 1-708-381-0334

Package Labeling:

Active Ingredients

Zinc Oxide 20.5%

Inactive Ingredients

Aloe Extract, Beeswax, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Oil, Tocopheryl Acetate (Vitamin E)

When Using This Product

avoid contact with the eyes

Stop Use and Talk to A Doctor If

condition worsens or does not improve after 7 days

Keep Out of the Reach of Children

If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately


Structured Label Content

Uses

• Helps treat and prevent diaper rash • Protects chafed skin due to wetness and helps seal out wetness

Purpose

Skin Protectant

Warnings

For external use only

Directions

Apply a layer of Barrier® to skin area you wish to protect. Change wet & spoiled diapers immediately. Clean the diaper area & allow to dry. Apply cream liberally & as often as necessary with each diaper change, especially at bedtime or anytime when exposed to wet diapers for a long period of time.

Questions?

Call 1-708-381-0334

Package Labeling:

Active Ingredients (Active ingredients)

Zinc Oxide 20.5%

Inactive Ingredients (Inactive ingredients)

Aloe Extract, Beeswax, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Oil, Tocopheryl Acetate (Vitamin E)

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Talk to A Doctor If (Stop use and talk to a doctor if)

condition worsens or does not improve after 7 days

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

If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately


Advanced Ingredient Data


Raw Label Data

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