Amish Origins Medicated Cream

Amish Origins Medicated Cream
SPL v26
SPL
SPL Set ID 547abe39-3af3-4d70-99dd-caf8d67feda2
Route
TOPICAL
Published
Effective Date 2022-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (8 g)
Inactive Ingredients
Water Safflower Oil Sunflower Seed Oil Glycereth-8 Esters Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Sodium Chloride Aloe Vera Leaf Hydrogenated Castor Oil Phenoxyethanol Caprylyl Glycol Chlorphenesin Eucalyptus Globulus Leaf Cinnamomum Camphora Whole Abies Sibirica Leaf Oil Methyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-01-01

Description

Menthol 8%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 8%

Uses:

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

Section 50565-1
  • Keep ointment out of reach of children
Section 51945-4

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
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.
Active Ingredient

Menthol 8%

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


Structured Label Content

Uses:

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

Section 50565-1 (50565-1)
  • Keep ointment out of reach of children
Section 51945-4 (51945-4)

Purpose

Topical Analgesic

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
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.
Active Ingredient

Menthol 8%

Inactive Ingredients (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


Advanced Ingredient Data


Raw Label Data

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