curetech enshield

curetech enshield
SPL v2
SPL
SPL Set ID 9e414f95-a9af-6399-e053-2995a90a72c4
Route
topical
Published
Effective Date 2014-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (3.8 g)
Inactive Ingredients
water sodium benzoate ceteth-20 aloe vera leaf alpha-tocopherol cetostearyl alcohol cetyl alcohol cholecalciferol glycerin lanolin mineral oil paraffin microcrystalline wax phenoxyethanol propylene glycol fd&c yellow no. 5 ponceau 4r vitamin a palmitate ethylhexylglycerin

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2019-02-07

Purpose

Skin Protectant

Description

Zinc Oxide (3.8%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, Ceteth-20, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Ethylhexylglycerin,FD&C Yellow No. 5, Fragrance, Glycerin, Lanolin, Microcrystalline Wax, Mineral Oil, Paraffin, Phenoxyethanol, Ponceau 4R, Propylene Glycol, Sodium Benzoate, Vitamin A Palmitate, Water

Description

Zinc Oxide (3.8%w/w)

Package Label

Active Ingredient

Zinc Oxide (3.8%w/w)

When Using This Product

■ do not get into eyes

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children

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


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, Ceteth-20, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Ethylhexylglycerin,FD&C Yellow No. 5, Fragrance, Glycerin, Lanolin, Microcrystalline Wax, Mineral Oil, Paraffin, Phenoxyethanol, Ponceau 4R, Propylene Glycol, Sodium Benzoate, Vitamin A Palmitate, Water

Package Label

Active Ingredient

Zinc Oxide (3.8%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)

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

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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