Ancalima Zinc Oxide 20%

Ancalima Zinc Oxide 20%
SPL v4
SPL
SPL Set ID 860e92cc-13fb-1810-e053-2991aa0a9a6e
Route
TOPICAL
Published
Effective Date 2019-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-04-08

Description

Zinc Oxide 20% w/w

Purpose

Diaper Rash Cream


Medication Information

Purpose

Diaper Rash Cream

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, 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

Diaper Rash Cream

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, 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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