THERA PLUS MAX STRENGTH LIDOCAINE PAIN RELIEF LIQUID- lidocaine hydrochloride liquid 
Fourstar Group USA, Inc.

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Thera Plus Max Strength Lidocaine Pain Relief Liquid

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

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:

Outer Package2Inner Package2

THERA PLUS MAX STRENGTH LIDOCAINE PAIN RELIEF LIQUID 
lidocaine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-098
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80684-098-0074 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/01/2024
Labeler - Fourstar Group USA, Inc. (140099503)

Revised: 11/2023
Document Id: 0b61e01d-3530-d2a1-e063-6294a90a513c
Set id: 0a228b06-0e1c-6c75-e063-6294a90a9a0e
Version: 2
Effective Time: 20231130
 
Fourstar Group USA, Inc.