Label: BURNAID BURN GEL- tea tree oil gel
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Contains inactivated NDC Code(s)
NDC Code(s): 51121-035-04, 51121-035-12 - Packager: Clear Healthcare LLC
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated March 19, 2014
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- PURPOSE
- Warning
- Inactive ingredients
- Directions
- PRINCIPAL DISPLAY PANEL - 3.5 g Packet Label
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INGREDIENTS AND APPEARANCE
BURNAID BURN GEL
tea tree oil gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51121-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tea Tree Oil (UNII: VIF565UC2G) (Tea Tree Oil - UNII:VIF565UC2G) Tea Tree Oil 10 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) PEG-7 Glyceryl Cocoate (UNII: VNX7251543) Trolamine (UNII: 9O3K93S3TK) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Lactic Acid (UNII: 33X04XA5AT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51121-035-12 3.5 g in 1 PACKET 2 NDC:51121-035-04 115 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 11/04/2013 Labeler - Clear Healthcare LLC (078886273)