MENTHOLATUM LIDOCAINE ICE- lidocaine hcl, menthol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Lidocaine HCl 4%, Menthol 1%
Available from:
The Mentholatum Company
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Lidocaine HCl - Topical anesthetic Menthol – Topical analgesic temporarily relieves pain
Authorization status:
OTC monograph not final
Authorization number:
10742-1389-1

MENTHOLATUM LIDOCAINE ICE- lidocaine hcl, menthol gel

The Mentholatum Company

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.

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Drug Facts

Active ingredients

Lidocaine HCl 4%

Menthol 1%

Purpos e

Lidocaine HCl - Topical anesthetic

Menthol – Topical analgesic

Us es

temporarily relieves pain

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

on large areas of the body or on cut, irritated or blistered skin

on puncture wounds

for more than one week without consulting a doctor

use only as directed

do not get into eyes

do not bandage tightly or apply external heat to the area of use

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

Directions

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, aloe barbadensis leaf juice, aminomethyl

propanol, bis-vinyl dimethicone/dimecthicone copolymer, C30-45 alkyl cetearyl dimethicone

crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, chlorphenesin, dicetyl

phosphate, dimethicone, edetate disodium, ethoxydiglycol, glycerin, glyceryl monostearate,

methoxypropanediol, phenoxyethanol, purified water, steareth-21

Package/Label Principal Display Panel

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

MENTHOLATUM LIDOCAINE ICE

lidocaine hcl, menthol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 742-138 9

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE HYDRO CHLO RIDE (UNII: V130 0 7Z41A) (LIDOCAINE -

LIDOCAINE HYDROCHLORIDE

40 mg

The Mentholatum Company

UNII:9 8 PI20 0 9 8 7)

ANHYDROUS

in 1 mL

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL, UNSPECIFIED

FORM - UNII:L7T10 EIP3A)

MENTHOL, UNSPECIFIED FORM

10 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)

DIMETHICO NE/VINYL DIMETHICO NE CRO SSPO LYMER ( SO FT PARTICLE) (UNII: 9 E4CO0 W6 C5)

CAPRYLYL TRISILO XANE (UNII: Q9 5M2P1KJL)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

CETETH-2 0 PHO SPHATE (UNII: 9 21FTA150 0 )

CHLO RPHENESIN (UNII: I6 70 DAL4SZ)

DIHEXADECYL PHO SPHATE (UNII: 2V6 E5WN9 9 N)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

DIETHYLENE GLYCO L MO NO ETHYL ETHER (UNII: A1A1I8 X0 2B)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

GLYCERIN METHYL ETHER (UNII: 42ESM1DR47)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

WATER (UNII: 0 59 QF0 KO0 R)

STEARETH-2 1 (UNII: 53J3F32P58 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 742-138 9 -1

1 in 1 CARTON

0 8 /0 1/20 18

1

8 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 8 /0 1/20 18

Labeler -

T he Mentholatum Company (002105757)

Revised: 11/2019

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