Label: BITEMD EXTERNAL ANALGESIC FIRST AID ANTISEPTIC (benzocaine, camphor- synthetic, and phenol liquid
- NDC Code(s): 79364-0932-1
- Packager: United Industries Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 23, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
For external use only
When using this product
- Do not get in eyes.
- Do not apply over large areas of the body or bandage.
- In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.
- Directions
- Other Information
- Adult and children 2 years and over
- Children under 2 years
- Inactive Ingredients
- Questions or Comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 14.7 mL Bottle Label
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INGREDIENTS AND APPEARANCE
BITEMD EXTERNAL ANALGESIC FIRST AID ANTISEPTIC
benzocaine, camphor (synthetic), and phenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79364-0932 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 0.0524 mg in 1 mL CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.03144 mg in 1 mL Phenol (UNII: 339NCG44TV) (Phenol - UNII:339NCG44TV) Phenol 0.01572 mg in 1 mL Inactive Ingredients Ingredient Name Strength Propylene Glycol (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79364-0932-1 14.7 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M017 01/01/2020 Labeler - United Industries Corporation (068527704) Establishment Name Address ID/FEI Business Operations Wisconsin Pharmacal 800873986 MANUFACTURE(79364-0932)