UTRASURE- otc antiprespirant drug product spray

UTRASURE by

Drug Labeling and Warnings

UTRASURE by is a Otc medication manufactured, distributed, or labeled by DermaRite Industries LLC, DermaRite Industries LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Aluminum Sesquichlorohydrate 15%

Purpose:

Anti-perspirant

Uses:

• Reduce underarm wetness
• 24 hour protection

Warnings:

• For external use only.
• Do not use on broken skin.
• Avoid contact with eyes. In case of contact, flush thoroughly with water.
• Stop use and ask doctor if you have Kidney Disease.

Warnings:

• Keep out of reach of children. If swallowed, contact physician or Poison Control Center right away.

Directions:

• Apply to under arms only.
• Hold in an upright position about 6 inches from the underarm and spray.

Other Information

• Store at room temperature (59°-86°F).
• You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047

Inactive Ingredients:

Fragrance, PEG-40 Castor Oil, Propylene Glycol, SD Alcohol 40-B, Water

Questions?

Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

UTRASURE 
otc antiprespirant drug product spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-266
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V)	ALUMINUM SESQUICHLOROHYDRATE	0.15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-266-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/24/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part350	02/24/2010

Labeler - DermaRite Industries LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
DermaRite Industries LLC		883925562	api manufacture(61924-266)