Natural Epsom Salt Granule
FDA Label NDC 52000-420
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Natural Epsom Salt (NDC 52000-420). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, indications & usage, warnings, otc - keep out of reach of children, other, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - Keep Out Of Reach Of Children
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.
Other
UNSCENTED EPSOM SALT IS FOR INTERNAL AND EXTERNAL USE. SCENTED EPSOM SALTS ARE FOR EXTERNAL USE ONLY.
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
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
Packaging
Natural Epsom Salt (52000 420)
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