Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e4a621d1-5687-413f-b0f6-a14ca4a21104
Route
TOPICAL
Published
Effective Date 2017-01-11
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 FINAL Active Since 2017-01-10

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%

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

Principal Display Panel


NDC 69842-955-04

CVS Health

Compare to active ingredients of Gold Bold Cornstarch Plus Baby Powder*

Medicated Corn Starch Baby Powder

TRIPLE ACTION RELIEF

Helps Soothe:





  • Minor skin irritation
  • Chafing
  • Diaper rash


Skin Protectant

NET WT 4 OZ (113 g)











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 condition worsens 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 right away.


Structured Label Content

Purpose

Skin Protectant

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

Principal Display Panel


NDC 69842-955-04

CVS Health

Compare to active ingredients of Gold Bold Cornstarch Plus Baby Powder*

Medicated Corn Starch Baby Powder

TRIPLE ACTION RELIEF

Helps Soothe:





  • Minor skin irritation
  • Chafing
  • Diaper rash


Skin Protectant

NET WT 4 OZ (113 g)











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 (Stop use and ask a doctor)

If condition worsens 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 right away.


Advanced Ingredient Data


Raw Label Data

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