NATURAL EPSOM SALT- magnesium sulfate granule

NATURAL Epsom Salt by

Drug Labeling and Warnings

NATURAL Epsom Salt by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient

Magnesium Sulfate USP 100%

Purpose

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

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

INDICATIONS & USAGE

INTERNAL USE
relieves occasional constipation (irregularity)
generally produces bowel movement in 1/2 to 6 hours

EXTERNAL USE
Relieves pain from minor sprains and bruises

WARNINGS

WARNINGS - Consult a doctor before use if you have:
 kidney disease
 a magnesium restricted diet
 stomach pain, nausea or vomiting
 noticed a sudden change in bowel habits that continues more than 2 weeks
already used a laxative for more than 1 week

Consult a doctor or pharmacist before using if you are taking any other prescription drugs.

Laxatives may affect how other drugs work.

When using this product, DO NOT USE more than directed.

Stop use and consult a doctor if:
As Laxative:
 you have rectal bleeding or failure to have a bowel movement after use
 you need to use a laxative for more than 1 week

As soaking solution:
 you have redness, irritation, swelling, or infection occurs
 do not use hot or warm soaks individuals with diabetes without consulting a doctor

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

SPL UNCLASSIFIED SECTION

UNSCENTED EPSOM SALT IS FOR INTERNAL AND EXTERNAL USE. SCENTED EPSOM SALTS ARE FOR EXTERNAL USE ONLY.

DIRECTIONS

  do not exceed more than 2 doses per day

• Age: Dose
• adults and children 12 years and older: 2 to 4 level teaspoons(10 to 20 grams) dissolved in a full glass (8oz) of water
• children 6 to under 12 years: 1 to 2 level teaspoons(5 to 10 grams) dissolved in a full glass (8oz) of water

Not recommended for children under 6 years of age.

INACTIVE INGREDIENT

None

SPL UNCLASSIFIED SECTION

REGULAR UNSCENTED

A soaking aid for minor sprains & bruises

Use as a saline laxative

Great for gardening

EXTERNAL USE

SORE FEET RELIEF: Add 1 cup of Epsom Salt to 1 gallon of warm water and soak for minimum 5 minutes at a time.

BATH SOAK: Add 2 cups of Epsom Salt under warm, running bath water. Soak for minimum 20 minutes to relieve tension and soothe sore tired muscles.

FIRST AID COMPRESS: Dissolve 2 cups of 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.

KEEP OUT OF REACH OF CHILDREN. Where prompt relief is not obtained or where there is evidence of infection, discontinue use and consult a doctor. Hot or warm soaks should not be used by individuals with diabetes except on advice of a doctor. AVOID CONTACT WITH EYES.

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

Distributed By:
Universal Distribution Center
96 Distribution Boulevard
Edison, NJ 08817
www.universaldc.com

Packaging

INGREDIENTS AND APPEARANCE

NATURAL EPSOM SALT 
magnesium sulfate granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-420
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE, UNSPECIFIED FORM	100 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-420-16	454 g in 1 BOX; Type 0: Not a Combination Product	11/01/2024
2	NDC: 52000-420-22	623 g in 1 BOX; Type 0: Not a Combination Product	11/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	11/01/2024

Labeler - Universal Distribution Center LLC (019180459)