Active ingredients

Lidocaine HCl 4%

Menthol 1%

Purpose

Lidocaine HCl - Topical anesthetic

Menthol – 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, swollen, or blistered skin
on puncture wounds
for more than one week without consulting a doctor

When using this product

use only as directed
do not get into eyes
do not bandage tightly or apply external heat (such as a heating pad) to the area of use

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or clear up and occur again within a few days
redness, rash, or irritation occurs

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years and over: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
children under 12 years: ask a doctor

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, bis-vinyl dimethicone/dimethicone copolymer, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, chlorphenesin, dicetyl phosphate, dimethicone, edetate disodium, glycerin, glyceryl stearate SE, phenoxyethanol, purified water, SD alcohol 40, steareth-21

Package/Label Principal Display Panel

DG HEALTH MAXIMUM STRENGTH COLD N HOT
lidocaine hcl, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-760
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE	40 mg in 1 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
STEARETH-21 (UNII: 53J3F32P58)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55910-760-01	1 in 1 CARTON	03/30/2020
1		49.6 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/30/2020

Labeler - DOLGENCORP, LLC (068331990)

Drug Facts