Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID bac18496-3b76-4faf-abde-968d79b718d8
Route
TOPICAL
Published
Effective Date 2025-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (20 g)
Inactive Ingredients
Cetostearyl Alcohol Ceteth-20 White Petrolatum Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-31

Description

Zinc Oxide 20% w/w

Purpose

First Aid Antibiotic


Medication Information

Purpose

First Aid Antibiotic

Description

Zinc Oxide 20% w/w

Uses

helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness. dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings

For external use only

Directions

apply liberally as often as necessary

For diaper rash:

• change wet or soiled diapers promptly

• cleanse the diaper area and allow to dry

• apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Do Not Use

• For external use only

• When using this product, avoid contact with the eyes

• Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Other Information

• Store at USP controlled room temperature 20-25°C (68-77°F)

• To open: unscrew cap, remove liner seal and replace cap.

• see carton or tube crimp for lot number and expiration date

Inactive Ingredients

Cetostearyl Alcohol, Cetomacrogol-1000, Lanoline Anhydrous, White Petroleum Jelly, Light Liquid Paraffin

Principal Display Panel

Zinc Oxide Ointment



Skin Protectant • 2 oz



Reorder No. xxxx



Individually Boxed • 12 Tubes per Pack



Each Tube Net Weight 2 oz



Gross Wt. 5.300 kg Net Wt. 4.075 kg



72 Tubes



Elixir

Stop Use and Ask A Doctor If

• condition persists or gets worse

• a rash or other allergic reaction develops

Keep Out of Reach of Children

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

Active Ingredient (in Each Gram)

Zinc Oxide 20% w/w

Ask A Doctor Before Use in Case Of

• deep or puncture wounds

• animal bites

• serious burns


Structured Label Content

Uses

helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness. dries the oozing and weeping of poison ivy, poison oak and poison sumac

Purpose

First Aid Antibiotic

Warnings

For external use only

Directions

apply liberally as often as necessary

For diaper rash:

• change wet or soiled diapers promptly

• cleanse the diaper area and allow to dry

• apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Do Not Use (Do not use)

• For external use only

• When using this product, avoid contact with the eyes

• Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Other Information (Other information)

• Store at USP controlled room temperature 20-25°C (68-77°F)

• To open: unscrew cap, remove liner seal and replace cap.

• see carton or tube crimp for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

Cetostearyl Alcohol, Cetomacrogol-1000, Lanoline Anhydrous, White Petroleum Jelly, Light Liquid Paraffin

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Zinc Oxide Ointment



Skin Protectant • 2 oz



Reorder No. xxxx



Individually Boxed • 12 Tubes per Pack



Each Tube Net Weight 2 oz



Gross Wt. 5.300 kg Net Wt. 4.075 kg



72 Tubes



Elixir

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

• condition persists or gets worse

• a rash or other allergic reaction develops

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.

Active Ingredient (in Each Gram) (Active Ingredient (in each gram))

Zinc Oxide 20% w/w

Ask A Doctor Before Use in Case Of (Ask a doctor before use in case of)

• deep or puncture wounds

• animal bites

• serious burns


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)