Cr-1189 Zinc Oxide 40% Ndc 70000-0469-1

Cr-1189 Zinc Oxide 40% Ndc 70000-0469-1
SPL v8
SPL
SPL Set ID 80c24e21-6aba-0c05-e053-2a91aa0a657f
Route
TOPICAL
Published
Effective Date 2019-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (40 g)
Inactive Ingredients
Lanolin Glycerin Yellow Wax Petrolatum Cod Liver Oil Talc Sorbitan Sesquioleate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-01-30
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
Label

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Warnings

For external use only

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Active Ingredient

Zinc oxide 40%

Other Information
  • store at 20°C to 25°C (68°F to 77°F)
  • may stain clothing
Inactive Ingredients

beeswax, cod liver oil, fragrance, glycerine, lanolin, sorbitan sesquioleate, talc, tocopheryl acetate, petrolatum

Questions and Comments?

1-888-396-2739

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

Structured Label Content

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Label

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Purpose

Skin Protectant

Warnings

For external use only

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Active Ingredient

Zinc oxide 40%

Other Information
  • store at 20°C to 25°C (68°F to 77°F)
  • may stain clothing
Inactive Ingredients

beeswax, cod liver oil, fragrance, glycerine, lanolin, sorbitan sesquioleate, talc, tocopheryl acetate, petrolatum

Questions and Comments? (Questions and comments?)

1-888-396-2739

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:21.317879 · Updated: 2026-03-14T23:10:42.831626