Medicated Cornstarch Baby Powder

Medicated Cornstarch Baby Powder
SPL v4
SPL
SPL Set ID e39032d1-c8cd-4a41-af10-126970b8ad38
Route
TOPICAL
Published
Effective Date 2016-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Starch, Corn (89.27 g) Zinc Oxide (16.95 g) Kaolin (4.52 g)
Inactive Ingredients
Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-09-01
Description

Corn Starch 79% Kaolin 4% Zinc Oxide 15%

Purpose

Skin Protectant

Medication Information

Purpose

Skin Protectant

Description

Corn Starch 79% Kaolin 4% Zinc Oxide 15%

Section 51945-4

uses
  • Prevents chafed skin and reduces minor skin irritations due to diaper rash
  • Helps protect from wetness
Purposes

Skin Protectant

Warnings

For external use only.

Directions

Babies: Change wet and soiled diaper promptly, cleanse the diaper area and allow to dry.  Apply powder liberally as often as necessary, with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged.  Apply powder close to the body away from child's face.  Carefully shake the powder into the diaper or into the hand and apply to diaper area.  

Adults and children 2 years and older: apply freely up to 3 or 4 times daily.  For best results, dry skin thoroughly before applying.

Active Ingredients

Corn Starch 79%

Kaolin 4%

Zinc Oxide 15%

Inactive Ingredients

Fragrance, Silica

When Using This Product
  • Avoid contact with eyes
  • Do not use on broken skin
  • Keep powder away from child's face to avoid inhalation which can cause breathing problems
Stop Use and Ask A Doctor If
  • If conditions worsen or symptoms do not get better within 7 days
Keep Out of Reach of Children.

If ingested, get medical help or contact a Poison Control Center immediately.

Structured Label Content

Section 51945-4 (51945-4)

uses (Uses)
  • Prevents chafed skin and reduces minor skin irritations due to diaper rash
  • Helps protect from wetness
Purposes

Skin Protectant

Warnings

For external use only.

Directions

Babies: Change wet and soiled diaper promptly, cleanse the diaper area and allow to dry.  Apply powder liberally as often as necessary, with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged.  Apply powder close to the body away from child's face.  Carefully shake the powder into the diaper or into the hand and apply to diaper area.  

Adults and children 2 years and older: apply freely up to 3 or 4 times daily.  For best results, dry skin thoroughly before applying.

Active Ingredients

Corn Starch 79%

Kaolin 4%

Zinc Oxide 15%

Inactive Ingredients (Inactive ingredients)

Fragrance, Silica

When Using This Product (When using this product)
  • Avoid contact with eyes
  • Do not use on broken skin
  • Keep powder away from child's face to avoid inhalation which can cause breathing problems
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • If conditions worsen or symptoms do not get better within 7 days
Keep Out of Reach of Children. (Keep out of reach of children.)

If ingested, get medical help or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:58.157818 · Updated: 2026-03-14T23:12:00.901105