K19 RELIEF- menthol liquid 
K19 LLC

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K19 SPRAY RELIEF

DRUG FACTS:

Active Ingredient:

Menthol 1.25%

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and stains.

Warnings:

Keep Out of reach of children.

  • If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions:

Additional Information:

Store at room temperature.

Other Ingredients:

Aqua (Deionized Water), Camphor, Glycerin, Glyceryl Laurate, SD-Alcohol 40B.

Package Labeling:

Label

K19 RELIEF 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83574-413
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL LAURATE (UNII: Y98611C087)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83574-413-00295 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/10/2023
Labeler - K19 LLC (090893478)

Revised: 11/2023
Document Id: 09766af0-0cc8-7466-e063-6294a90abbed
Set id: e2e1ca96-1ae8-4c99-b8de-ce26754292f9
Version: 2
Effective Time: 20231106
 
K19 LLC