THERACARE ROLL-ON MENTHOL 16% PAIN RELIEF LIQUID- menthol liquid

TheraCare Roll-on Menthol 16% Pain Relief Liquid by

Drug Labeling and Warnings

TheraCare Roll-on Menthol 16% 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 Menthol 16% Pain Relief Liquid

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

• arthritis
• simple backache
• muscle strains
• sprains
• bruises
• cramps

Warnings

For external use only

When using this product

• use only as directed. Read and follow all directions and warnings on this carton.
• avoid contact with eyes and mucous membranes
• rare cases of serious burns have been reported with products of this type
• do not apply to wounds or damaged, broken or irritated skin
• do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
• a transient burning sensation may occur upon application but generally disappears in several days
• if severe burning sensation occurs, discontinue use immediately
• do not expose the area treated with product to heat or direct sunlight
• avoid applying into skin folds

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
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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
• massage into painful area until thoroughly absorbed into skin
• repeat as necessary, but no more than 3 to 4 times daily
• IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 12 years or younger:ask a doctor

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer(60000 MPA.S), aminomethyl propanol, capsaicin, glycerin, isopropyl

myristate, propylene glycol, SD alcohol, water

Principal Display Panel

INGREDIENTS AND APPEARANCE

THERACARE ROLL-ON MENTHOL 16% PAIN RELIEF LIQUID 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-089
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.16 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPSAICIN (UNII: S07O44R1ZM)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
AMINOMETHYL PROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-089-01	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(71101-089)