Active Ingredient
Benzocaine USP 20%
L-Menthol USP 1%
Medicaine Sting And Bite Swab
FDA Label NDC 67777-405
11 label sections · Submitted to the FDA by Dynarex Corporation · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Medicaine Sting And Bite (NDC 67777-405). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use(s), warnings, when using section, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Analgesic
Analgesic
Use(S)
For the temporary relief of pain and itching associated with insect bites and stings.
Warnings
For External Use Only
When Using Section
• Do not use in the eyes
• Not for prolonged use
• Do not apply other medication to the same affected areas unless advised by a doctor
Stop Use And Ask A Doctor If
Condition persists, or if a rash, irritation, or allergic reaction develops.
Keep Out Of Reach Of Children
If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Reverse cardboard sleeve then crush at dot between thumb and forefinger. Once solution has saturated tip, apply topically to the sting or bit. May be used on affected area(s) up to 4 times per day
Not for use with children less than 2 years old without medical advise.
Other Information
Store at room temperature 15°-30°C (59°-86°F) away from light.
Inactive Ingredients
D&C Green Dye #5, D&C Yellow Dye #10, FD&C Blue Dye #1, Isopropyl Alcohol, PEG 300 NF, Purified Water USP
Label
1407 Medicaine Sting and Bite Ampule
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