MENTHOL- amish origins medicated cream 
Amish Origins LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Amish Origins Medicated Cream

Active Ingredient

Menthol 8%

Purpose

Topical Analgesic

Uses:

Arthritis Pain, Sore Joints and Muscles, Sore Throat, Sinus Trouble, Restless Leg Syndrome

Warnings

  • For External Use Only, As Directed!
  • Avoid contact with eyes or other sensitive areas.
  • If prone to allergic reaction from asprin or salicylate, consult your doctor before using.
  • If conditions persist pore than seven days, consult your doctor
  • If pregnant or breast-feeding, ask a health professional before use.
  • Do not bandange tightly or use a heating pad
  • May irritate sensitive skin

  • Keep ointment out of reach of children

Directions

​Adults and children over 12 years:

  • ​Apply freely to affected areas. Rub well
  • ​Colds: ​Apply on chest, back and neck.
  • ​Head Colds: Apply around nostrils, on forehead and behind ears.  Place small amount in vaporizer for aid.
  • ​Sore Throat:​ Apply  liberally on throat and neck for sore throats

Children 12 years or younger.

  • Consult your physician.

INACTIVE INGREDIENTS

Water, Carthamus Tinctorius (Hybrid Safflower) Seed Oil, Cetyl PEG/PPG-10/1 Dimethicone, Aloe Barbadensis (Aleo Vera) Leaf Juice, Beeswax, Hydrogenated Castor oil, Caprylyl Glycol, Phenoxyethanol, Eucalyptus Globulus Leaf Oil, Chlorphenesin, Cinnamomum Camphora Bark Oil, Abies Sibirica Needle Oil, Methyl Salicylate, Sodium Chloride

PainReliefCream

MENTHOL 
amish origins medicated cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62212-252
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
CINNAMOMUM CAMPHORA WHOLE (UNII: 0B27814T7X)  
ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62212-252-0199.22 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2013
Labeler - Amish Origins LLC (079239259)

Revised: 11/2022
 
Amish Origins LLC