Cmc-shield

Cmc-shield
SPL v1
SPL
SPL Set ID 58fffc68-579e-0dfc-e053-2991aa0afb27
Route
TOPICAL
Published
Effective Date 2017-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (3.8 g)
Inactive Ingredients
Alpha-tocopherol Methylparaben Paraffin Petrolatum Polyethylene Glycol 6000 Steareth-20 Trolamine Vitamin A Water D&c Red No. 21 Cetyl Alcohol Lavender Oil Propylparaben Sodium Fd&c Yellow No. 5 Ceteth-10 Cetostearyl Alcohol Lanolin Mineral Oil Aloe Vera Leaf Cholecalciferol Glycerin Phenoxyethanol Polysorbate 60

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-09-01
Description

Zinc Oxide (3.8%)

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Zinc Oxide (3.8%)

Uses
  • helps treat and prevent diaper rash
  • temporarily protects from minor cuts, scrapes
  • burns dries the oozing and weeping of poison ivy, poison oak, poison sumac

Warnings

For external use only

Directions
  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • for poison ivy, oak, and sumac
  • apply ointment liberally as needed
Package Label

Active Ingredient

Zinc Oxide (3.8%)

Other Information
  • Store at a room temperature 15-30° C (59-86 F)
  • Avoid excessive heat
Inactive Ingredients

aloe vera leaf, alpha-tocopherol, ceteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender, methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium, steareth-20, trolamine, vitamin-A, water, FDC Yellow No. 5, DC Red No.21

When Using This Product
  • do not get into eyes
Stop Use and Ask A Doctor If

Condition worsens or symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away

Structured Label Content

Uses (USES)
  • helps treat and prevent diaper rash
  • temporarily protects from minor cuts, scrapes
  • burns dries the oozing and weeping of poison ivy, poison oak, poison sumac

Purpose (PURPOSE)

Skin Protectant

Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)
  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • for poison ivy, oak, and sumac
  • apply ointment liberally as needed
Package Label (PACKAGE LABEL)

Active Ingredient (ACTIVE INGREDIENT)

Zinc Oxide (3.8%)

Other Information (OTHER INFORMATION)
  • Store at a room temperature 15-30° C (59-86 F)
  • Avoid excessive heat
Inactive Ingredients (INACTIVE INGREDIENTS)

aloe vera leaf, alpha-tocopherol, ceteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender, methylparaben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium, steareth-20, trolamine, vitamin-A, water, FDC Yellow No. 5, DC Red No.21

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 or symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

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: 2026-02-15T11:56:24.861732 · Updated: 2026-03-14T22:54:51.534540