ASPIERA WOUND CARE AND ANTISEPTIC- allantoin, benzethonium chloride ointment

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Allantoin 0.5%

Benzethonium Chloride 0.1%

Purpose

Allantoin - Skin Protectant

Benzethonium Chloride - First Aid Antiseptic

Uses

• Helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips.
  
• Topical antiseptic to help decrease the risk of skin infection.
  

Warnings

For external use only.
When using this product, do not get into eyes.
Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.
Do not use on deep or puncture wounds, animal bites or serious burns.

Keep out of reach of children.

If swallowed, call poison control or seek medical help.

Directions

Wash and dry affected skin. Apply a thin layer of Aspiera. Cover affected area with a clean bandage. Repeat procedure 1-3 times daily until skin improves. Store at room temperature.

Inactive Ingredients

bentonite, cera alba (organic beeswax), magnesium oxide, peppermint oil, sage oil, silver oxide, simmondsia chinensis (jojoba) seed oil, zinc oxide

SPL UNCLASSIFIED SECTION

Made in USA. Distributed by Aspiera Medical, a division of Aidance Skincare & Topical Solutions, LLC. (+1) 401-400-0047 www.aspiera.com
Protected by US and international patents granted and pending. Aspiera™ and Faster Penetration for Faster Healing™ are trademarks of Aidance Skincare (C) 2012 Aidance Skincare.

PRINCIPAL DISPLAY PANEL - 44g Label

Aspiera
Wound Care and Antiseptic Ointment
Faster Penetration for Faster Healing™

INGREDIENTS AND APPEARANCE

ASPIERA WOUND CARE AND ANTISEPTIC 
allantoin, benzethonium chloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24909-617
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5 g  in 100 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENTONITE (UNII: A3N5ZCN45C)
JOJOBA OIL (UNII: 724GKU717M)
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
PEPPERMINT OIL (UNII: AV092KU4JH)
SAGE OIL (UNII: U27K0H1H2O)
SILVER OXIDE (UNII: 897WUN6G6T)
WHITE WAX (UNII: 7G1J5DA97F)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24909-617-44	44 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	05/31/2012

Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Skincare & Topical Solutions, LLC		018950611	manufacture, label