Dyve Comfort B: Package Insert and Label Information

DYVE COMFORT B- menthol and benzocaine gel
AmperSand Biopharmaceuticals

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.

Benzocaine 20%

Menthol 1%

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 20-25ºC (68-77ºF)

Inactive ingredients

benzyl alcohol, isopropyl palmitate, lecithin, palm kernel oil, poloxamer 407, polyglyceryl-4 esters, sodium hydroxide, water

Questions?

1-833-DYVE-BIO

DYVE COMFORT B benzocaine, lidocaine gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70458-104 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 1 g in 100 g BENZOCAINE (BENZOCAINE) BENZOCAINE 20 g in 100 g

Inactive Ingredients Ingredient Name Strength ISOPROPYL PALMITATE LECITHIN, SOYBEAN POLOXAMER 407 BENZYL ALCOHOL WATER POLYGLYCERYL-4 STEARATE PALM KERNEL OIL POLYGLYCERYL-4 OLEATE SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70458-104-20 1 JAR in 1 BOX contains a JAR 1 200 g in 1 JAR This package is contained within the BOX (70458-104-20)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/01/2018

Labeler — AmperSand Biopharmaceuticals (080111681)

Revised: 03/2018 AmperSand Biopharmaceuticals