THERACARE ROLL-ON LIDOCAINE PAIN RELIEF LIQUID- lidocaine hci liquid

TheraCare Roll-on Lidocaine Pain Relief Liquid by

Drug Labeling and Warnings

TheraCare Roll-on Lidocaine Pain Relief Liquid by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Nantong Health & Beyond Hygienic Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

TheraCare Roll-on Lidocaine Pain Relief Liquid 

Active ingredient

Lidocaine HCl 4%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain

Warnings

For external use only

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.

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERACARE ROLL-ON LIDOCAINE PAIN RELIEF LIQUID 
lidocaine hci liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-087
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOHEXADECANE (UNII: 918X1OUF1E)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
ALCOHOL (UNII: 3K9958V90M)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARETH-21 (UNII: 53J3F32P58)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-087-01	1 in 1 CARTON	09/01/2025
1		73 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/01/2025

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Nantong Health & Beyond Hygienic Products Inc		421280161	manufacture(71101-087)