SPEARMINT AND MENTHOL SCENTED NATURAL EPSOM SALT- magnesium sulfate powder

Spearmint and Menthol scented Natural Epsom Salt by

Drug Labeling and Warnings

Spearmint and Menthol scented Natural Epsom Salt by is a Otc medication manufactured, distributed, or labeled by Anhui Twowin Machinery Imp. & Exp. Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient ..................................................................... Purpose

Magnesium Sulfate USP (Epsom Salt)

Internal Use ....................................................................... Saline Laxative

External Use .................................................................... Soaking Solution

PURPOSE

Uses (Internal)

• Relieves occasional constipation (irregularity)
• Generally produces bowel movements in 1/2 to 6 hours

Uses (External)

• Relieves pain from minor sprains and bruises

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions - For Internal Use as a Laxative

• do not exceed more than 2 doses per day
• may be taken as a single daily dose or in divided doses
• dissolve each dose in a full (8 ounces) of liquid

• Age: Dose
• adults and children 12 years and older: 2 to 4 level teaspoons (10 to 20 grams) daily
• children 6 to under 12 years: 1 to 2 level teaspoons (5 to 10 grams) daily

Not recommended for children under 6 years of age.

INDICATIONS & USAGE

Natural Epsom Salt

Magnesium Sulfate U.S.P.

Soaking Solution

Saline Laxative

Soothes Minor Aches, Sprains & Sore Muscles

Calming & Rejuvenating

SORE FEET RELIEF: Add one cup of Amoray Care® Epsom Salt to one gallon of warm water and soak for at least 5 minutes at a time.

BATH SOAK: Add two cups of Amoray Care® Epsom Salt under warm running bath water to release its gentle aroma. Amoray Care® Epsom Salt helps relieve tension and provides a soothing, relaxing experience.  Soak for at least 20 minutes.

First Aid Compress: Dissolve 2 cups of Amoray Care® Epsom Salt into two cups of hot water to make a compress, apply as a wet dressing with a towel to: soothe bruises & sprains, take the sting out of insect bites, draw out splinters, alleviate pain from sports and overexertion.

Kkeep out of reach of children.  Where prompt relief is not obtained or where there is evidence of infection, discontinue use and consult a physician. Hot or warm soaks should not be used by individuals with diabetes except on advice of a physician. Avoid contact with eyes.

EPSOM SALT WITHOUT SCENT CAN BE APPLIED FOR BOTH INTERNAL AND EXTERNAL USE, SCENTED EPSOM SALTS CAN BE APPLIED FOR EXTERNAL USE ONLY.

Store in a cool, dry place out of direct sunlight. Package sold by weight not volume, some settling may occur during shipment. If caking occurs, tap pouch gently to free granules.

WARNINGS

Warnings  Ask a doctor before use if you have:

Kidney disease

a magnesium restricted diet

abdominal pain, nausea or vomiting

noticed a sudden change in bowel habits that persists over a period of 2 weeks

already used a laxative for a period longer than 1 week

Ask a doctor or pharmacist before use if you are presently taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product, do not use more than directed.

Stop and consult a doctor if:

As laxative:  you have rectal bleeding or fail to have a bowel movement after use.  This may indicate a serious condition.  You need to use a laxative for more than 1 week

As soaking solution:  you have redness, irritation, swelling, or infection occurs  hot or warm soaks should not be used by individuals with diabetes except with the advice of a physician

If pregnant or breast-feeding, ask a health professional before use.

EPSOM SALT WITHOUT SCENT CAN BE APPLIED FOR BOTH INTERNAL AND EXTERNAL USE, SCENTED EPSOM SALTS CAN BE APPLIED FOR EXTERNAL USE ONLY.

INACTIVE INGREDIENT

Ingredients: 

Natural Magnesium Sulfate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPEARMINT AND MENTHOL SCENTED NATURAL EPSOM SALT 
magnesium sulfate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69232-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE	10 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
SPEARMINT (UNII: J7I2T6IV1N)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69232-005-01	454 g in 1 PACKAGE; Type 0: Not a Combination Product	01/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/27/2016

Labeler - Anhui Twowin Machinery Imp. & Exp. Co., Ltd. (421251758)

Establishment
Name	Address	ID/FEI	Business Operations
Anhui Twowin Machinery Imp. & Exp. Co., Ltd.		421251758	manufacture(69232-005)