Active Ingredients
Benzocaine 20%
Menthol 1%
Dyve Comfort B
FDA Label NDC 70458-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ampersand Biopharmaceuticals for the product Dyve Comfort B (NDC 70458-104). 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 ingredients, purpose, uses, warnings, do not use, when using this product:, stop using and ask a doctor if, if pregnant or breastfeeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
Temporarily relieves minor pain
Warnings
For external use only
Do Not Use
On large areas of the body or on cut, irritated or swollen skin
On puncture wounds
For more than one week without consulting a doctor
When Using This Product:
Use only as directed
Read and follow all direction and warnings on this carton
Do not allow contact with eyes
Do not bandage or apply local heat to the area of use
Stop Using And Ask A Doctor If
Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days
If Pregnant Or Breastfeeding,
ask a health professional before use
Keep Out Of Reach Of Children And Pets.
If swallowed, get medical help or contact a Poison Control Center right away
Directions
Adults and children over 12 years: Apply generously (about the thickness of a nickel) to the affected area as needed, not to exceed 3 applications in a 24 hour period. Children 12 years or younger: ask a doctor
Other Information
Store at 20-25°C (68-77°F)
Inactive Ingredients
benzyl alcohol, isopropyl palmitate, lecithin, palm kernel oil, poloxamer 407, polyglyceryl-4 esters, sodium hydroxide, water
Questions?
1-833-DYVE-BIO
Package Label.Principal Display Panel
Dyve Comfort B (200 gram jar box)
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