Zinc Oxide 20%

Zinc Oxide 20%
SPL v1
SPL
SPL Set ID 22cd1e7a-5448-b3f6-e063-6394a90a880d
Route
TOPICAL
Published
Effective Date 2013-05-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Lanolin Cetostearyl Alcohol Ceteth-20 Light Mineral Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-05-23

Description

Zinc Oxide 20% w/w

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 20% w/w

Uses

■ helps treat and prevent diaper rash ■ dries the oozing and weeping of ■ poison ivy ■ poison oak ■ poison sumac

Section 50565-1

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

Warnings

For external use only

Directions

■ for diaper rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak sumac ■ apply ointment liberally as often as needed

Package Label

Active Ingredient

Zinc Oxide 20% w/w

Other Information

■ store at 59-86F (15-30C)

Inactive Ingredients

cetostearyl alcohol, cetomacrogol 1000, lanolin, light liquid paraffin, white soft parrafin

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 in a few days ■ if you are allergic to any of these ingredients


Structured Label Content

Uses

■ helps treat and prevent diaper rash ■ dries the oozing and weeping of ■ poison ivy ■ poison oak ■ poison sumac

Section 50565-1 (50565-1)

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

Purpose

Skin Protectant

Warnings

For external use only

Directions

■ for diaper rash ■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak sumac ■ apply ointment liberally as often as needed

Package Label

Active Ingredient

Zinc Oxide 20% w/w

Other Information

■ store at 59-86F (15-30C)

Inactive Ingredients

cetostearyl alcohol, cetomacrogol 1000, lanolin, light liquid paraffin, white soft parrafin

When Using This Product (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 (Stop use and ask a doctor if)

■ the condition worsens ■ symptoms last more than 7 days or clear up and occur again in a few days ■ if you are allergic to any of these ingredients


Advanced Ingredient Data


Raw Label Data

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