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NDC 59779-0071-43 Cooling Epsom Rub 11.7 mg/mL Details

Cooling Epsom Rub 11.7 mg/mL

Cooling Epsom Rub is a TOPICAL GRANULE, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy, Inc. The primary component is MENTHOL.

Product Information

NDC	59779-0071
Product ID	59779-071_8d105399-8aa1-4a09-a68f-a467d5447698
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cooling Epsom Rub
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	GRANULE, FOR SOLUTION
Route	TOPICAL
Active Ingredient Strength	11.7
Active Ingredient Units	mg/mL
Substance Name	MENTHOL
Labeler Name	CVS Pharmacy, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 59779-0071-43 (59779007143)

Pricing Information	N/A
NDC Package Code	59779-071-43
Billing NDC	59779007143
Package	473 mL in 1 BOTTLE, PLASTIC (59779-071-43)
Marketing Start Date	2015-05-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 21feddfc-3451-4c7b-9b8a-f4ff230171af Details

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 ara ot more than 3 to 4 times daily

children under 2 years of age - consult a doctor

Directions for use as Relaxing Soak Solution:

For external use only. Pour liberally into warm wateer 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. Individuals with diabetes should not use hot or warm water soaks unless advised by a physician. Keep out of rach 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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

2015 CVS/Pharmacy

CVS.com

1-800-SHOP CVS

principal display panel

CVS

Health

Menthol

Cooling

Epsom Rub

PAIN RELIEVING

SOAKING SOLUTION

Temporarily relieves pain asociated with:

Arthritis
Minor aches
Sprains
Tired feet

16 FL OZ (1 PT) 473 mL

INGREDIENTS AND APPEARANCE

COOLING EPSOM RUB

menthol granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-071
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-071-43	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/05/2015

Labeler - CVS Pharmacy, Inc (062312574)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(59779-071)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(59779-071)

Revised: 2/2022

Document Id: 8d105399-8aa1-4a09-a68f-a467d5447698

Set id: 21feddfc-3451-4c7b-9b8a-f4ff230171af

Version: 15

Effective Time: 20220209