THERA PLUS MAX STRENGTH LIDOCAINE PAIN RELIEF LIQUID- lidocaine hydrochloride liquid

Thera Plus Max Strength Lidocaine Pain Relief Liquid by

Drug Labeling and Warnings

Thera Plus Max Strength Lidocaine Pain Relief Liquid by is a Otc medication manufactured, distributed, or labeled by Fourstar Group USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Lidocaine HCI 4%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain

Warnings

For external use only.

Flammable keep away from fire or flame

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 directions and warnings in this carton.  do not allow contact with the eyes and mucous membranes  do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use  do not use at the same time as other topical analgesics

Stop use and ask a doctor if

condition worsens  redness is present  irritation develops  symptoms persist for more than 7 days or clear up and occur again within a few days

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

Other information

• store at 20° - 25°C (68° - 77°F)
• store in a cool dry place away from direct sunlight

Inactive ingredients

acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, cetearyl alcohol, ceteth-10 phosphate, cyclopentasiloxane, dicetyl phosphate, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, sd alcohol, steareth-21, water

Questions or comments?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Package Labeling:

INGREDIENTS AND APPEARANCE

THERA PLUS MAX STRENGTH LIDOCAINE PAIN RELIEF LIQUID 
lidocaine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80684-098
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOHEXADECANE (UNII: 918X1OUF1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80684-098-00	74 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/01/2024

Labeler - Fourstar Group USA, Inc. (140099503)