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

Purpose

Skin Protectant

Description

Zinc Oxide 20 %


Medication Information

Warnings

For external use only

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

Purpose

Skin Protectant

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
Other Information

■ Store at 15°C – 30°C (59°F – 86°F)

Inactive Ingredients

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

Description

Zinc Oxide 20 %

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

Active Ingredient

Zinc Oxide 20 %

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

Warnings

For external use only

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

Purpose

Skin Protectant

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
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

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

Active Ingredient (Active ingredient)

Zinc Oxide 20 %

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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