MEDICATED CORNSTARCH BABY POWDER- active corn starch powder

Medicated Cornstarch Baby Powder by

Drug Labeling and Warnings

Medicated Cornstarch Baby Powder by is a Otc medication manufactured, distributed, or labeled by Davion, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Corn Starch 79%

Kaolin 4%

Zinc Oxide 15%

Purposes

Skin Protectant

Uses

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

Warnings

For external use only.

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.

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.

Inactive ingredients

Fragrance, Silica

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDICATED CORNSTARCH BABY POWDER 
active corn starch powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42669-231
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STARCH, CORN (UNII: O8232NY3SJ) (STARCH, CORN - UNII:O8232NY3SJ)	STARCH, CORN	89.27 g  in 113 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	16.95 g  in 113 g
KAOLIN (UNII: 24H4NWX5CO) (KAOLIN - UNII:24H4NWX5CO)	KAOLIN	4.52 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42669-231-04	113 g in 1 BOX; Type 0: Not a Combination Product	09/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2016

Labeler - Davion, Inc. (174542928)

Registrant - Davion, Inc. (174542928)