Thera Plus Max Strength Lidocaine Pain Relief Liquid

Thera Plus Max Strength Lidocaine Pain Relief Liquid
SPL v2
SPL
SPL Set ID 0a228b06-0e1c-6c75-e063-6294a90a9a0e
Route
TOPICAL
Published
Effective Date 2023-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Aloe Vera Leaf Aminomethylpropanol Cetostearyl Alcohol Ceteth-10 Phosphate Cyclomethicone 5 Dihexadecyl Phosphate Dimethicone Edetate Disodium Anhydrous Ethylhexylglycerin Glyceryl Monostearate Isohexadecane Phenoxyethanol Steareth-21 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-01

Description

Lidocaine HCI 4%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Lidocaine HCI 4%

Uses

temporarily relieves minor pain

Warnings

For external use only.

Flammable •keep away from fire or flame

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

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

Drug Facts

Active Ingredient

Lidocaine HCI 4%

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

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

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.


Structured Label Content

Uses

temporarily relieves minor pain

Purpose

Topical analgesic

Warnings

For external use only.

Flammable •keep away from fire or flame

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

Do Not Use (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

Drug Facts

Active Ingredient (Active ingredient)

Lidocaine HCI 4%

Other Information (Other information)
  • store at 20° - 25°C (68° - 77°F)
  • store in a cool dry place away from direct sunlight
Package Labeling:

Inactive Ingredients (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? (Questions or comments?)

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

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)