Label: BENZOCAINE AND TRICLOSAN- first aid spray aerosol, spray
- NDC Code(s): 56104-005-03
- Packager: Premier Brands of America Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated December 31, 2015
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- Active ingredient
For external use only.
Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF
When using this product
- avoid contact with the eyes
- do not apply over large area of the body
- use only as directed
Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Stop use and ask a doctor if
- conditions worsens
- symptoms persists for more than 7 days or clear up and occur again within a few days
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
BENZOCAINE AND TRICLOSAN
first aid spray aerosol, spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56104-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 17 g in 85 g TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 0.11 g in 85 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) ISOBUTANE (UNII: BXR49TP611) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56104-005-03 85 g in 1 CANISTER; Type 0: Not a Combination Product 01/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2013 Labeler - Premier Brands of America Inc. (080051232)