Glint Enshield

Glint Enshield
SPL v1
SPL
SPL Set ID 76286a04-0343-de77-e053-2991aa0a3f20
Route
TOPICAL
Published
Effective Date 2018-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (3.8 g)
Inactive Ingredients
Aloe Vera Leaf Alpha-tocopherol Ceteth-10 Cetostearyl Alcohol Cetyl Alcohol 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 2018-09-19

Description

Zinc Oxide (3.8%w/w)

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide (3.8%w/w)

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

Warnings

For external use only

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

Package Label

Active Ingredient

Zinc Oxide (3.8%w/w)

Other Information

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

Inactive Ingredients

aloe vera leaf, alpha-tocopherol, ceteth-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

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

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

Warnings

For external use only

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

Package Label

Active Ingredient

Zinc Oxide (3.8%w/w)

Other Information

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

Inactive Ingredients (Inactive ingredients)

aloe vera leaf, alpha-tocopherol, ceteth-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

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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