COOLING EPSOM RUB- menthol granule, for solution

Cooling Epsom Rub by

Drug Labeling and Warnings

Cooling Epsom Rub by is a Otc medication manufactured, distributed, or labeled by Vi-Jon, Inc, Vi-Jon,Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

COOLING EPSOM RUB 
menthol granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0494
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	menthol	11.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CAPSICUM (UNII: 00UK7646FG)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0494-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/24/2017

Labeler - Vi-Jon, Inc (790752542)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon,Inc		790752542	manufacture(0869-0494)