Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 69c1db68-508a-e6e1-e053-2a91aa0a8568
Route
TOPICAL
Published
Effective Date 2018-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (13 g)
Inactive Ingredients
Water Mineral Oil Microcrystalline Wax Petrolatum Yellow Wax Sorbitan Sesquioleate Dimethicone Aloe Vera Leaf Peg-30 Dipolyhydroxystearate Phenoxyethanol Potassium Hydroxide Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-04-09

Description

Zinc oxide 13%

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc oxide 13%

Uses

■ helps treat and prevent diaper rash

■ soothes and relieves irritated skin

■ protects your baby's skin from wetness

Warnings

For external use only

Directions

■ change wet and soiled diapers promptly ■ cleanse the diaper area ■ allow to dry ■ ointment should be applied at every diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Package Label



Active Ingredient

Zinc oxide 13%

Other Information

■ store at 20º to 25ºC (68º to 77ºF)

Inactive Ingredients

water, mineral oil, petrolatum, yellow wax, dimethicone, sorbitan sesquioleate, microcrystalline wax, PEG-30 dipolyhydroxysterate, phenoxyethanol, potassium hydroxide, alpha-tocopherol acetate, aloe vera extract

When Using This Product

■ avoid contact with eyes

Stop Use and Ask A Doctor If

■ condition worsens or does not improve within 7 days or symptoms clear up and occur again in a few days.

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

■ soothes and relieves irritated skin

■ protects your baby's skin from wetness

Purpose

Skin Protectant

Warnings

For external use only

Directions

■ change wet and soiled diapers promptly ■ cleanse the diaper area ■ allow to dry ■ ointment should be applied at every diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Package Label



Active Ingredient

Zinc oxide 13%

Other Information

■ store at 20º to 25ºC (68º to 77ºF)

Inactive Ingredients

water, mineral oil, petrolatum, yellow wax, dimethicone, sorbitan sesquioleate, microcrystalline wax, PEG-30 dipolyhydroxysterate, phenoxyethanol, potassium hydroxide, alpha-tocopherol acetate, aloe vera extract

When Using This Product (When using this product)

■ avoid contact with eyes

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

■ condition worsens or does not improve within 7 days or symptoms clear up and occur again in a few days.

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

All Sections (JSON)