Theracare Roll-on Lidocaine Pain Relief Liquid

Theracare Roll-on Lidocaine Pain Relief Liquid
SPL v1
SPL
SPL Set ID e942d447-754d-4683-9c99-57c7e83d7ea8
Route
TOPICAL
Published
Effective Date 2025-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Glyceryl 1-stearate Aloe Vera Leaf Aminomethylpropanol Isohexadecane Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Alcohol Cyclomethicone 5 Water Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Dihexadecyl Phosphate Dimethicone 350 Ethylhexylglycerin Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Ceteth-10 Phosphate Edetate Disodium Anhydrous Cetostearyl Alcohol Phenoxyethanol Steareth-21

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-01
Description

TheraCare Roll-on Lidocaine Pain Relief Liquid 

Purpose

Topical analgesic

Medication Information

Purpose

Topical analgesic

Description

TheraCare Roll-on Lidocaine Pain Relief Liquid 

Uses

temporarily relieves minor pain

Section 42229-5

TheraCare Roll-on Lidocaine Pain Relief Liquid 

Section 51945-4

Warnings

For external use only

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

Active Ingredient

Lidocaine HCl 4%

Inactive Ingredients

Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer (60000 MPA.S), aloe barbadensis leaf juice, aminomethylpropanol,

ceteth-10 phosphate, cetostearyl alcohol, cyclomethicone 5, dicetyl phosphate, dimethicone 350, dimethicone/vinyl dimethicone

crosspolymer (soft particle), disodium EDTA, ethylhexylglycerin, glyceryl 1 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate

copolymer (100000 MPA.S at 1.5%), isohexadecane, phenoxyethanol, SD alcohol, steareth-21, water

Questions Or Comments

Call 1-866-326-1313

When Using This Product
  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with the eyes and mucus membranes
  • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the 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

Flammable■ Keep away from fire or flame

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 (1-800-222-1222) right away.

Structured Label Content

Uses

temporarily relieves minor pain

Section 42229-5 (42229-5)

TheraCare Roll-on Lidocaine Pain Relief Liquid 

Section 51945-4 (51945-4)

Purpose

Topical analgesic

Warnings

For external use only

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

Active Ingredient (Active ingredient)

Lidocaine HCl 4%

Inactive Ingredients (Inactive ingredients)

Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer (60000 MPA.S), aloe barbadensis leaf juice, aminomethylpropanol,

ceteth-10 phosphate, cetostearyl alcohol, cyclomethicone 5, dicetyl phosphate, dimethicone 350, dimethicone/vinyl dimethicone

crosspolymer (soft particle), disodium EDTA, ethylhexylglycerin, glyceryl 1 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate

copolymer (100000 MPA.S at 1.5%), isohexadecane, phenoxyethanol, SD alcohol, steareth-21, water

Questions Or Comments (Questions or comments)

Call 1-866-326-1313

When Using This Product (When using this product)
  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with the eyes and mucus membranes
  • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the 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

Flammable■ Keep away from fire or flame

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 (1-800-222-1222) right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:03.763649 · Updated: 2026-03-14T23:10:14.816739