Human Otc Drug Label

Human Otc Drug
SPL v4
SPL
SPL Set ID 1b580bf6-f217-5c0f-e063-6294a90a012e
Route
TOPICAL
Published
Effective Date 2024-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
White Petrolatum Cetostearyl Alcohol Light Mineral Oil Polyoxyl 20 Cetostearyl Ether

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-11

Description

Active Ingredient Purpose Zinc Oxide 20% w/w .


Medication Information

Warnings and Precautions

For External Use Only

When using this product Do not get into eyes Do not use over large areas of the body

Stop use and ask a doctor if The condition worsens Symptoms last more than 7 days or clear up and occur again within a few days You are allergic to any of these

ingredients

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

Indications and Usage

Directions

For poison ivy, oak, and sumac: apply as needed.

Uses

Dries the oozing and weeping of poison: Ivy Oak Sumac

Description

Active Ingredient Purpose Zinc Oxide 20% w/w .

Dosage

Active Ingredient Purpose

Zinc Oxide 20% w/w .

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 55105-1

PURPOSE SINK PROTECTANT

Inactive

Inactive Ingredients

Cetostearyl Alcohol, Light Mineral Oil, Macrogol Cetostearyl Ether 20, White Petrolatum

Oxide Zinc

OXIDE OINMENT


Structured Label Content

Dosage (DOSAGE)

Active Ingredient Purpose

Zinc Oxide 20% w/w .

Indications and Usage (34067-9)

Directions

For poison ivy, oak, and sumac: apply as needed.

Uses

Dries the oozing and weeping of poison: Ivy Oak Sumac

Warnings and Precautions (34071-1)

For External Use Only

When using this product Do not get into eyes Do not use over large areas of the body

Stop use and ask a doctor if The condition worsens Symptoms last more than 7 days or clear up and occur again within a few days You are allergic to any of these

ingredients

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

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 55105-1 (55105-1)

PURPOSE SINK PROTECTANT

Inactive (INACTIVE)

Inactive Ingredients

Cetostearyl Alcohol, Light Mineral Oil, Macrogol Cetostearyl Ether 20, White Petrolatum

Oxide Zinc (OXIDE ZINC)

OXIDE OINMENT


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)