Zinc Oxide 20%, A+ Health, Made In India

Zinc Oxide 20%, A+ Health, Made In India
SPL v1
SPL
SPL Set ID 1549500a-0941-0fba-e063-6394a90a564e
Route
TOPICAL
Published
Effective Date 2024-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (20 g)
Inactive Ingredients
Ceteth-20 Cetostearyl Alcohol Light Mineral Oil White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-01

Description

Zinc Oxide 20 %

Purpose

Skin Protectant


Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide 20 %

Uses

■ Dries the oozing and weeping of poison • ivy • oak • sumac

■ Helps treat and prevent diaper rash

■ Protects chafed skin due to diaper rash and helps seal out wetness

Section 42229-5

Manufactured for:

Bionpharma Inc.

Princeton, NJ 08540

MADE IN INDIA

L0000798

KBP0581L-0

R0324

GUJ/DRUGS/G/25/2134

Section 51945-4

NDC 69452-450-58

dye-free • paraben-free

• phthalate-free • fragrance-free

a+ health TM

healing ointment

zinc oxide 20% / skin protectant

• protects chafed skin due to diaper rash and helps seal out wetness

• dries the oozing and weeping of poison ivy, oak and sumac

net wt. 15 oz

Warnings

For external use only

Directions

■ For poison ivy, oak & sumac: apply as needed

■ For Diaper Rash

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply ointment liberally as often as necessary, with each diaper change, especially at bed time or anytime when exposure to wet diapers may be prolonged
Active Ingredient

Zinc Oxide 20 %

Other Information

■ Store at 15°C – 30°C (59°F – 86°F)

Inactive Ingredients

ceteareth 20, cetostearyl alcohol, light mineral oil, white petrolatum

When Using This Product

do not get into eyes.

Stop Use and Ask A Doctor If

■ condition worsens

■ symptoms last more than 7 days or clear up and occur again within 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

■ Dries the oozing and weeping of poison • ivy • oak • sumac

■ Helps treat and prevent diaper rash

■ Protects chafed skin due to diaper rash and helps seal out wetness

Section 42229-5 (42229-5)

Manufactured for:

Bionpharma Inc.

Princeton, NJ 08540

MADE IN INDIA

L0000798

KBP0581L-0

R0324

GUJ/DRUGS/G/25/2134

Section 51945-4 (51945-4)

NDC 69452-450-58

dye-free • paraben-free

• phthalate-free • fragrance-free

a+ health TM

healing ointment

zinc oxide 20% / skin protectant

• protects chafed skin due to diaper rash and helps seal out wetness

• dries the oozing and weeping of poison ivy, oak and sumac

net wt. 15 oz

Purpose

Skin Protectant

Warnings

For external use only

Directions

■ For poison ivy, oak & sumac: apply as needed

■ For Diaper Rash

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply ointment liberally as often as necessary, with each diaper change, especially at bed time or anytime when exposure to wet diapers may be prolonged
Active Ingredient (Active ingredient)

Zinc Oxide 20 %

Other Information (Other information)

■ Store at 15°C – 30°C (59°F – 86°F)

Inactive Ingredients (Inactive ingredients)

ceteareth 20, cetostearyl alcohol, light mineral oil, white petrolatum

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)

■ condition worsens

■ symptoms last more than 7 days or clear up and occur again within 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

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