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
- 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.
Drug Label Information
Updated January 12, 2023
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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 not final part348 01/01/2020 Labeler - United Industries Corporation (068527704) Establishment Name Address ID/FEI Business Operations Wisconsin Pharmacal 800873986 MANUFACTURE(79364-0932)