DYVE COMFORT L- menthol, lidocaine gel

Dyve Comfort L by

Drug Labeling and Warnings

Dyve Comfort L by is a Otc medication manufactured, distributed, or labeled by AmperSand Biopharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 4%

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DYVE COMFORT L 
menthol, lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70458-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-4 STEARATE (UNII: VLC3W3U1PE)
PALM KERNEL OIL (UNII: B0S90M0233)
POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70458-103-20	1 in 1 BOX	04/01/2018
1		200 g in 1 JAR; 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	04/01/2018

Labeler - AmperSand Biopharmaceuticals (080111681)