SPL v3
SPL
SPL Set ID c6f28076-0ffc-4850-b544-656532355537
Route
TOPICAL
Published
Effective Date 2018-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (40 g)
Inactive Ingredients
Petrolatum Mineral Oil Paraffin Castor Oil Balsam Peru

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-07-22

Description

Zinc Oxide, 40%

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Zinc Oxide, 40%

Uses

helps treat and prevent diaper rash, Protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only.

Tube Label

Package Label

Active Ingredient

Zinc Oxide, 40%

Other Information

Storage temperature: not to exceed 30oC (86oF),

Remove foil seal from the tube's tip,

Use with infants, children, and adults,

Will stain clothing and fabric

Directions for Use

change wet and soiled diaper immediately, cleanse the diaper area and allow to dry, apply ointment liberally as often as necessary with each diaper change and especially when exposured to wet diapers for a prolonged period of time, such as bedtime

Inactive Ingredients

Castor Oil, Mineral Oil, Paraffin, Peruvian Balsam, White Petrolatum

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If

condition worsens or does not improve after 7 days

Keep Out of Reach of Children

to prevent accidential ingestion.  If swallowed, seek medical help or call Poison Control Center immediately.


Structured Label Content

Uses

helps treat and prevent diaper rash, Protects chafed skin due to diaper rash and helps seal out wetness

Purpose

Skin protectant

Warnings

For external use only.

Tube Label (Tube label)

Package Label (Package label)

Active Ingredient (Active ingredient)

Zinc Oxide, 40%

Other Information (Other information)

Storage temperature: not to exceed 30oC (86oF),

Remove foil seal from the tube's tip,

Use with infants, children, and adults,

Will stain clothing and fabric

Directions for Use

change wet and soiled diaper immediately, cleanse the diaper area and allow to dry, apply ointment liberally as often as necessary with each diaper change and especially when exposured to wet diapers for a prolonged period of time, such as bedtime

Inactive Ingredients (Inactive ingredients)

Castor Oil, Mineral Oil, Paraffin, Peruvian Balsam, White Petrolatum

When Using This Product (When using this product)

avoid contact with the eyes

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

condition worsens or does not improve after 7 days

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

to prevent accidential ingestion.  If swallowed, seek medical help or call Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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