cr-1189 zinc oxide 40% ndc 70000-0469-1

cr-1189 zinc oxide 40% ndc 70000-0469-1
SPL v2
SPL
SPL Set ID 2992285b-bcdb-c0da-e063-6294a90ac650
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 pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate sorbitan sesquioleate .alpha.-tocopherol acetate starch, corn

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-01-30
Purpose

Skin Protectant

Description

Zinc oxide 40%

Medication Information

Warnings

For external use only

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

Skin Protectant

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
  • wipe tip clean after each use
  • reapply firmly to lock applicator when not in use
Other Information
  • store at 59°F to 87°F
Inactive Ingredients

beeswax, cod liver oil, glycerine, lanolin, sorbitan sesquioleate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, tocopheryl acetate, petrolatum

Description

Zinc oxide 40%

Label

Section 50565-1

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

Active Ingredient

Zinc oxide 40%

Questions and Comments?

1-877-469-8877

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

Warnings

For external use only

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

Skin Protectant

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
  • wipe tip clean after each use
  • reapply firmly to lock applicator when not in use
Other Information
  • store at 59°F to 87°F
Inactive Ingredients

beeswax, cod liver oil, glycerine, lanolin, sorbitan sesquioleate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, tocopheryl acetate, petrolatum

Label

Section 50565-1 (50565-1)

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

Active Ingredient

Zinc oxide 40%

Questions and Comments? (Questions and comments?)

1-877-469-8877

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: 2026-02-15T12:06:48.837694 · Updated: 2026-03-14T23:09:49.100948