Amish Origins Medicated Cream

Manufacturer
Amish Origins LLC
Effective date
2024-12-03
Label type
HUMAN OTC DRUG LABEL
Version
26
Source
full-release
Hydrated at
2026-06-01 00:40:33

Label at a glance#

ProductMenthol
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

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

Dosage and administration

​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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 8%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep ointment out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

​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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

7 oz w pump7 oz w pump3.5 jar3.5 jar14 oz jar14 oz jar3.5 oz w pump3.5 oz w pump

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
727161menthol 8 % Topical CreamPSN26
727161menthol 80 MG/ML Topical CreamSCD26
727161menthol 8 % Topical CreamSY26

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62212-252-01Menthol99.22 g in 1 BOTTLECREAM99.2226
62212-252-02Menthol99.22 g in 1 BOTTLE, PUMPCREAM99.2226
62212-252-03Menthol400 g in 1 BOTTLECREAM40026
62212-252-04Menthol198.45 g in 1 BOTTLE, PUMPCREAM198.4526

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62212-252MENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]26Current NDC, Legacy NDC, 4 package rows20241207_547abe39-3af3-4d70-99dd-caf8d67feda2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A5
MENTHOLACTIVE MOIETYL7T10EIP3A5
ABIES SIBIRICA LEAF OILINACTIVE INGREDIENTXRY0V4VZKZ5
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X5
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U5
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0X5
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZ5
CINNAMOMUM CAMPHORA WHOLEINACTIVE INGREDIENT0B27814T7X5
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E65
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEY5
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022Y5
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T5
SAFFLOWER OILINACTIVE INGREDIENT65UEH262IS5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X5
SUNFLOWER SEED OIL GLYCERETH-8 ESTERSINACTIVE INGREDIENT358X17CAT05
WATERINACTIVE INGREDIENT059QF0KO0R5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62212-25262212-252-01, 62212-252-02, 62212-252-03, 62212-252-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii+route
5 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii+route
15 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii+route
10 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii+route
15 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii+route
5 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii+route
15 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii+route
15 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii+route
10 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii+route
15 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii+route
10 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii+route
5 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii+route
5 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii+route
15 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii+route
15 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii+route
15 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii+route
10 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii+route
15 equally ranked IID candidates
SAFFLOWER OILSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii+route
5 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MentholAMISH ORIGINS MEDICATEDAmish Origins LLC547abe39-3af3-4d70-99dd-caf8d67feda22024-12-03WarningsExact identifier
ndc (package): 62212-252-02
ndc (package): 62212-252-01
ndc (package): 62212-252-04
ndc (package): 62212-252-03
ndc (product): 62212-252
ndc11 (package): 62212025203
ndc11 (package): 62212025202
ndc11 (package): 62212025204
ndc11 (package): 62212025201
spl id: 28656961-9c32-9983-e063-6394a90ae6e4
spl set id: 547abe39-3af3-4d70-99dd-caf8d67feda2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.