H-E-B Medicated Corn Starch Foot Powder: Package Insert and Label Information

H-E-B MEDICATED CORN STARCH FOOT POWDER- menthol powder
Davion, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Menthol 1.0%

Purpose

External Analgesic

Uses

Temporary relief of pain and itch associate with:

• Minor Cuts
• Sunburn
• Insect Bites
• Scrapes
• Minor Burns
• Minor Skin Irritations

Warnings

• For external use only
• Avoid contact with eyes

Stop use and ask a doctor if

• Condition worsens
• Symptoms persist for more than 7 days or clear up and occur again within few days

Keep out of reach of children

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 2 years and older — Apply freely upto 3 or 4 times daily
• Children under 2 years — Ask a doctor
• For best results, dry skin throughly before applying

Inactive ingredients

Zea Mays (Corn) Starch, Tricalcium Phosphate, Sodium Bicarbonate, Benzethonium Chloride, Eucalyptus Oil, Peppermint Oil.

PRINCIPAL DISPLAY PANEL

NDC 42669-218-10

Compare to Gold Bond ® Medicated Foot Powder active ingredient*

H-E-B Medicated Corn Starch Foot Powder

TRIPLE RELIEF FORMULA

• Controls Odor
• Absorbs Moisture
• Relieves Itching

Talc-Free

NET WT. 10 OZ (283g)

H-E-B MEDICATED CORN STARCH FOOT POWDER menthol powder

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42669-218 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 1 g in 100 g

Inactive Ingredients Ingredient Name Strength STARCH, CORN TRICALCIUM PHOSPHATE SODIUM BICARBONATE BENZETHONIUM CHLORIDE EUCALYPTUS OIL PEPPERMINT OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42669-218-10 283 g in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/22/2018

Labeler — Davion, Inc (174542928)

Registrant — Davion, Inc (174542928)

Establishment
Name	Address	ID/FEI	Operations
Davion, Inc		174542928	manufacture (42669-218)

Revised: 08/2018 Davion, Inc