DYVE COMFORT L- menthol, lidocaine 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.

----------

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

Dyve Comfort L box

DYVE COMFORT L 
menthol, lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70458-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70458-103-201 in 1 BOX04/01/2018
1200 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2018
Labeler - AmperSand Biopharmaceuticals (080111681)

Revised: 3/2018
Document Id: 67e42947-3e06-c72c-e053-2991aa0adb99
Set id: 67e42947-3e05-c72c-e053-2991aa0adb99
Version: 1
Effective Time: 20180320
 
AmperSand Biopharmaceuticals