SPL v4
SPL
SPL Set ID cac77320-b5cf-4edf-9693-ebabfb61390c
Route
TOPICAL
Published
Effective Date 2023-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (400 mg)
Inactive Ingredients
Butylated Hydroxyanisole Cod Liver Oil Lanolin Petrolatum Talc Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2002-01-09
Description

Drug Facts

Purpose

Skin protectant

Medication Information

Purpose

Skin protectant

Description

Drug Facts

Uses
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Section 42229-5

Drug Facts

Section 51945-4

Principal Display Panel - Carton Label

NDC 11527-058-41

Dr. Sheffield's

Made in the USA

Diaper Rash

Ointment

40% Zinc Oxide Skin Protectant

• Promotes healing

• Relieves chafing

• Paraben free

Helps Treat and

Prevent Diaper Rash

NET WT. 2 oz. (56g)

Directions
  • 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 bedtime or anytime when exposure to wet diapers may be prolonged
Active Ingredient

Zinc Oxide 40%

Other Information

store at room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredients

BHA, Cod liver oil, Fragrance, Lanolin, Petrolatum, Talc, Water

When Using This Product
  • avoid contact with 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
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness
Section 42229-5 (42229-5)

Drug Facts

Section 51945-4 (51945-4)

Principal Display Panel - Carton Label

NDC 11527-058-41

Dr. Sheffield's

Made in the USA

Diaper Rash

Ointment

40% Zinc Oxide Skin Protectant

• Promotes healing

• Relieves chafing

• Paraben free

Helps Treat and

Prevent Diaper Rash

NET WT. 2 oz. (56g)

Purpose

Skin protectant

Directions
  • 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 bedtime or anytime when exposure to wet diapers may be prolonged
Active Ingredient (Active ingredient)

Zinc Oxide 40%

Other Information (Other information)

store at room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredients (Inactive ingredients)

BHA, Cod liver oil, Fragrance, Lanolin, Petrolatum, Talc, Water

When Using This Product (When using this product)
  • avoid contact with 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:24.407593 · Updated: 2026-03-14T23:01:55.379030