Otc - Active Ingredient
Active ingredient Purpose
Magnesium Sulfate USP (Epsom Salts)
External use Soaking solution
Internal Use Saline Laxative
Epsom Salt
FDA Label NDC 51345-099
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Beauty Systems, Inc. for the product Epsom Salt (NDC 51345-099). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
External: Relieves pain from minor sprains and bruises
Internal: Relieves occasional constipation (irregularity)
generally produces bowel movement in 1/2 to 6 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion or overdose, seek medical attention or contact a Poison Control Center immediately.
Indications & Usage
When using this product, do not use more than directed.
Stop use and consult a doctor if:
As a soaking solution
- you experience redness, irritation, swelling , or infection
As a laxative
- you have no bowel movements within six hours or experience rectal bleeding-these could be signs of a serious condition
- you need a laxative for more than a week
Warnings
Warnings:
Laxative- Do not give to children under six years of age except under the advice and supervision of a physician.
- For occasional use only. Serious side effects from prolonged use or overdose may occur.
Do not take this product except under the advice and supervision of a physician if you:
- Have kidney disease
- Are taking prescription medication
- Have a magnesium restricted diet
Ask a doctor before if you have
As a soaking solution
- redness or swelling present
- evidence of an infection
- diabetes - hot and warm soaks should not be used by individuals with diabetes except on advice of a physician
As a laxative
- Stomach pain
- Nausea
- Kidney disease
- A sudden change in bowel habits that lasts over 2 weeks
If pregnant or breast feeding, consult a physician before use
Other information
Dissolve before use
Dosage & Administration
Directions
- Do not exceed more than 2 doses per day, if neccessary repeat dosage in 4 hours
For External use
As a soaking solution: pour 2 cups of Epsom Salts under warm, running bath water. Soak for 20 minutes for to relieve sore,tired muscles.
As a warm compress: Dissolve 1 cup of Epsom Salts in 1 quart of warm water. Using a towel, apply solution to the affected area for 15-30 minutes to reduce pain and and swelling. Repeat as needed.For internal use
As a laxative 2-4 level teaspoons dissolved in a full glass (8oz) of water.
adults and children 12 years and older
children 6 to 12 years of age 1-2 level teaspoons dissolved in a full glass (8oz) of water.
not recommended for children under 6 years of age
Inactive Ingredient
This product contains no inactive ingredients
Image Of Bag Back (Back)
Package Label.Principal Display Panel
Dr. Teal's
Therapeutic solutions
Epsom Salt Soaking Solution
Magnesium Sulfate USP
Sooths aches, pains, sprains and stings
Helps relieve muscle tension
Made in U.S.A. with pure Epsom Salt
Net Wt. 2.72 Kg 6 lbs
Image Of Bag Front (Front)
* Please review the disclaimer below.
