FDA Label for Epsom Salt Soaking Solution

View Indications, Usage & Precautions

Epsom Salt Soaking Solution Product Label

The following document was submitted to the FDA by the labeler of this product Advanced Beauty Systems, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient                                     Purpose

Magnesium Sulfate USP (Epsom Salts)     

External use                                          Soaking solution

Internal Use                                           Saline Laxative     


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










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







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