drug facts

drug facts
SPL v3
SPL
SPL Set ID 2e4f1d9b-35ba-4f7e-8fa0-df1af9f61f95
Route
topical
Published
Effective Date 2013-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (1.8 g)
Inactive Ingredients
aloe vera leaf alpha-tocopherol ceteth-10 cetostearyl alcohol cetyl acetate cholecalciferol glycerin lanolin lavender oil methylparaben mineral oil paraffin petrolatum phenoxyethanol polyethylene glycol 6000 polysorbate 60 propylparaben sodium steareth-20 trolamine vitamin a water fd&c yellow no. 5 d&c red no. 21

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2013-05-27

Purpose

Skin Protectant

Description

Zinc Oxide (1.8%w/w)


Medication Information

Warnings

For external use only

Uses

■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns dries the oozing and weeping of: ■ Poison ivy ■ poison oak ■ poison sumac

Purpose

Skin Protectant

Directions

■ 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 and sumac ■ apply ointment liberally as needed

Other Information

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

Inactive Ingredients

aloe vera leaf, alpha-tocopherol, aeteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender

methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium

steareth-20, trolamine, vitamin A, water, FDC Yellow No.5, DC Red No.21

Description

Zinc Oxide (1.8%w/w)

Section 50565-1

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

Package Label

Active Ingredient

Zinc Oxide (1.8%w/w)

When Using This Product

■ do not get into eyes

Stop Use and Ask A Doctor If

if conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician


Structured Label Content

Warnings

For external use only

Uses

■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns dries the oozing and weeping of: ■ Poison ivy ■ poison oak ■ poison sumac

Purpose

Skin Protectant

Directions

■ 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 and sumac ■ apply ointment liberally as needed

Other Information

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

Inactive Ingredients (Inactive ingredients)

aloe vera leaf, alpha-tocopherol, aeteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender

methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium

steareth-20, trolamine, vitamin A, water, FDC Yellow No.5, DC Red No.21

Section 50565-1 (50565-1)

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

Package Label

Active Ingredient

Zinc Oxide (1.8%w/w)

When Using This Product (When using this product)

■ do not get into eyes

Stop Use and Ask A Doctor If (Stop Use and ask a doctor if)

if conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician


Advanced Ingredient Data


Raw Label Data

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