HOT/COLD MENTHOL 16% ROLL-ON- hot/cold menthol 16% roll-on liquid 
Humco Holding Group, Inc

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Private Label Hot/Cold Menthol 16% Roll-On

Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

When using this product: use only as directed. Do not bandage tightly or use with a heating pad. Avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. If you experience pain, swelling, or blistering of the skin where an OTC topical muscle and joint pain reliever was applied, stop using the product and seek professional attention immediately. These products produce local warmth or coolness.

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, SD Alcohol 40 (30%Z), Triethanolamine, Purified Water.

Temporarily relieves minor muscle and joint pain associated with arthritis, simple backache, muscle strains, sprains, bruises.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Topical analgesic

Menthol 16%

Equate Label

pain

HOT/COLD MENTHOL 16% ROLL-ON 
hot/cold menthol 16% roll-on liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9131
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALCOHOL (UNII: 3K9958V90M)  
CAPSAICIN (UNII: S07O44R1ZM)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0395-9131-9774 mL in 1 CONTAINER; Type 0: Not a Combination Product12/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/21/2018
Labeler - Humco Holding Group, Inc (825672884)
Registrant - Pharma Nobis, LLC (118564114)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Nobis, LLC118564114label(0395-9131) , pack(0395-9131) , analysis(0395-9131) , manufacture(0395-9131)

Revised: 12/2023
Document Id: 0c93883b-eed9-0f96-e063-6394a90ae9aa
Set id: a8bf9744-9979-13c1-e053-2a95a90a30aa
Version: 3
Effective Time: 20231215
 
Humco Holding Group, Inc