NDC | 59397-3310-1, 59397-3310-2 |
Set ID | 70df2ef5-44d3-446f-98d0-557b5f2bdd2b |
Category | HUMAN OTC DRUG LABEL |
Packager | S. C. Johnson & Son, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
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Drug Facts
Active Ingredients Purpose
Benzocaine 5%...........................................................................Analgesic, Anesthetic, Antipuritic
Phenol 1.35%.............................................................................First Aid Antiseptic
Camphor 3.0%...........................................................................Topical Analgesic
- Purpose
- 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
- In case of deep or puncture wounds, animal bites, or serious burns consult a doctor
- Do not bandage.
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Directions
- Clean the affected area
- Apply a small amount to the bite area while massaging with sponge tip applicator. If itching persists, apply again in 10-15 minutes
- For ticks and bees, remove tick or stinger before treatment
- Adults and children 2 years and over: Apply to affected area 1 to 3 times daily
- Children under 2 years: Consult a doctor
- Inactive Ingredients
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OFF BITE AND ITCH RELIEF FIRST AID ANTISEPTIC
benzocaine, phenol, camphor solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59397-3310 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5 mg in 100 mL PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 1.35 mg in 100 mL CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 3 mg in 100 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59397-3310-1 1 in 1 CARTON 11/01/2013 1 14.79 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/01/2013 Labeler - S. C. Johnson & Son, Inc. (006091417) Registrant - Wisconsin Pharmacal Company (800873986) Establishment Name Address ID/FEI Business Operations Wisconsin Pharmacal Company 800873986 manufacture(59397-3310)