drug facts

drug facts
SPL v1
SPL
SPL Set ID 5a8a9fda-6b60-4087-81a2-45e1ef5d1b1e
Route
topical
Published
Effective Date 2015-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (40 g)
Inactive Ingredients
butylated hydroxyanisole cod liver oil ethylhexylglycerin lanolin oil mineral oil petrolatum phenoxyethanol talc water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2015-07-01
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
  • HELPS SEAL OUT WETNESS
Purpose

SKIN PROTECTANT

Directions
  • CHANGE WET AND SOILED DIAPERS PROMPTLY
  • CLEAN THE DIAPER AREA AND ALLOW TO DRY
  • APPLY OINTMENT LIBERALLY AS OFTEN AS REQUIRED WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGED.
Other Information

STORE BETWEEN 20°-25°C (68°-77°F)

Inactive Ingredients

BHA, COD LIVER OIL, ETHYLHEXYLGLYCERIN, FRAGRANCE (PARFUM), LANOLIN, MINERAL OIL, PETROLATUM, PHENOXYETHANOL, TALC, WATER (AQUA)

Description

ZINC OXIDE 40%

Label Copy

Do Not Use On
  • DEEP PUNCTURE WOUNDS
  • ANIMAL BITES
  • SERIOUS BURNS
Active Ingredient

ZINC OXIDE 40%

Questions Or Comments?

1-888-309-9030

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Stop Using This Product 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 (WARNINGS)

FOR EXTERNAL USE ONLY

Uses (USES)
  • HELPS TREAT AND PREVENT DIAPER RASH
  • PROTECTS CHAFED SKIN DUE TO DIAPER RASH
  • HELPS SEAL OUT WETNESS
Purpose (PURPOSE)

SKIN PROTECTANT

Directions (DIRECTIONS)
  • CHANGE WET AND SOILED DIAPERS PROMPTLY
  • CLEAN THE DIAPER AREA AND ALLOW TO DRY
  • APPLY OINTMENT LIBERALLY AS OFTEN AS REQUIRED WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGED.
Other Information (OTHER INFORMATION)

STORE BETWEEN 20°-25°C (68°-77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

BHA, COD LIVER OIL, ETHYLHEXYLGLYCERIN, FRAGRANCE (PARFUM), LANOLIN, MINERAL OIL, PETROLATUM, PHENOXYETHANOL, TALC, WATER (AQUA)

Label Copy (LABEL COPY)

Do Not Use On (DO NOT USE ON)
  • DEEP PUNCTURE WOUNDS
  • ANIMAL BITES
  • SERIOUS BURNS
Active Ingredient (ACTIVE INGREDIENT)

ZINC OXIDE 40%

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-888-309-9030

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Stop Using This Product and Ask A Doctor If (STOP USING THIS PRODUCT 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: 2026-02-15T11:55:57.467833 · Updated: 2026-03-14T22:54:02.195419