87308-003

87308-003
SPL v2
SPL
SPL Set ID 47f588a2-a69b-cffe-e063-6294a90a0ed4
Route
CUTANEOUS
Published
Effective Date 2026-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (1 U)
Inactive Ingredients
Mineral Oil Cellulose Gum Polyisobutylene (1000 Mw) Lysine Alpha-tocopherol Acetate Melaleuca Alternifolia (tea Tree) Leaf Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-09

Description

Zinc oxide 1%

Purpose

Skin Protection


Medication Information

Purpose

Skin Protection

Description

Zinc oxide 1%

Use

Promotes the healing of cold sores, covering and protecting the affected area from bacterial infection.

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Irritation occurs or discomfort persists.

Section 50567-7

Do not use with other topical products on the same area unless directed by a doctor.

Warnings

For external use only

Avoid contact with eyes

Flammable

Keep away from heat or flame

Directions

Apply at the first sign of cold sore symptoms (tingling, itching or pain)

Clean and dry the affected area

Take out a cold sore patch

Gently press and seal the patch to the affected area

Wash your hands after applying the patch

Replace the patch every 8 to 12 hours, or sooner if it loosens

Do Not Use

If you are allergic to any of the ingredients

On broken skin unless directed by a doctor

Other Information

Store in a cool, dry place

Cold sores are contagious. Avoid sharing personal items that contact the cold sore

Wash your hands before and after touching the cold sore or applying the patch

If you are pregnant or breastfeeding, please consult a healthcare professional before use

Active Ingredient(s)

Zinc oxide 1%

Inactive Ingredients

Mineral Oil, Cellulose Gum, Polyisobutene, Lysine, Calendula Officinalis,Tocopheryl Acetate, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Package Label Principal Display Panel


Structured Label Content

Use

Promotes the healing of cold sores, covering and protecting the affected area from bacterial infection.

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Irritation occurs or discomfort persists.

Section 50567-7 (50567-7)

Do not use with other topical products on the same area unless directed by a doctor.

Purpose

Skin Protection

Warnings

For external use only

Avoid contact with eyes

Flammable

Keep away from heat or flame

Directions

Apply at the first sign of cold sore symptoms (tingling, itching or pain)

Clean and dry the affected area

Take out a cold sore patch

Gently press and seal the patch to the affected area

Wash your hands after applying the patch

Replace the patch every 8 to 12 hours, or sooner if it loosens

Do Not Use (Do not use)

If you are allergic to any of the ingredients

On broken skin unless directed by a doctor

Other Information (Other information)

Store in a cool, dry place

Cold sores are contagious. Avoid sharing personal items that contact the cold sore

Wash your hands before and after touching the cold sore or applying the patch

If you are pregnant or breastfeeding, please consult a healthcare professional before use

Active Ingredient(s)

Zinc oxide 1%

Inactive Ingredients (Inactive ingredients)

Mineral Oil, Cellulose Gum, Polyisobutene, Lysine, Calendula Officinalis,Tocopheryl Acetate, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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