Utrasure (Otc Antiprespirant Drug Product) Spray [Dermarite Industries Llc] -

UTRASURE (OTC ANTIPRESPIRANT DRUG PRODUCT) SPRAY [DERMARITE INDUSTRIES LLC]
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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.
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INGREDIENTS AND APPEARANCE

UTRASURE
otc antiprespirant drug product spray

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

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

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

Labeler - DermaRite Industries LLC (883925562)

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

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