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Cooling Epsom Rub by Vi-Jon, Inc

Medically reviewed on May 3, 2017

Dosage form: granule, for solution
Ingredients: menthol 11.7mg in 1mL
Labeler: Vi-Jon, Inc
NDC Code: 0869-0494

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.

Active ingredients

Menthol (1.25% w/w)

Purpose

Topical analgesic

Use

For the temporary relief of minor aches and pains of muscle joints associated with simple backache, arthritis, strains, bruises and sprains

Warnings

For external use only

Flammable
  • keep away from fire or flame, heat, spark, electrical

when using this product
  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

condtion worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults children 2 years of age and older - apply to affected area not more than 3 to 4 times daily

children under 2 years of age - consult a doctor

For external use as a relaxing soak solution pour liberally into warm water no more than 4 times daily.

Caution: If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician. Hot or warm soaks should not be used by individuals with diabetes except on the advice of a physician. Keep out of reach of children.

Other information
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • will produce serious gastric disturbances if take internally
  • fumes can be acutely irritating to respiratory system.  Avoid inhaling this product

Inactive ingredents

water, isopropyl alcohol, Capsicum Frutescens fruit extract, methyl saicylate, magnesium sulfate, blue 1

Adverse Reactions

Manufactured by: Vi-Jon Inc., St. Louis, MO 63114

Questions or Conments? 1-888-593-0563

Principal display panel

mountain

falls

relaxing

soak

solution

cooling

pain

relief

cooling

sports rub

pain relieving &

soaking solution

temporarily relieved pains

associated with:

  • arthritis
  • minor muscular aches
  • aching joints

16 FL OZ  (1PT) 473 mL

COOLING EPSOM RUB 
menthol granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0494
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
menthol (MENTHOL) menthol11.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
ISOPROPYL ALCOHOL 
CAPSICUM 
METHYL SALICYLATE 
MAGNESIUM SULFATE, UNSPECIFIED FORM 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:0869-0494-43473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/24/2017
Labeler - Vi-Jon, Inc (790752542)
Registrant - Vi-Jon, Inc (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon,Inc790752542manufacture(0869-0494)

 
Vi-Jon, Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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