EPSOM SALT SOAKING SOLUTION- magnesium sulfate granule 
Advanced Beauty Systems, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dr. Teals Magnesium sulfate U.S.P.

Active ingredient                                     Purpose

Magnesium Sulfate USP (Epsom Salts)     

External use                                          Soaking solution

Internal Use                                           Saline Laxative     

Uses

External: Relieves pain from minor sprains and bruises

Internal: Relieves occasional constipation (irregularity)

generally produces bowel movement in 1/2 to 6 hours.

Keep out of reach of children. In case of accidental ingestion or overdose, seek medical attention or contact a Poison Control Center immediately.

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:

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

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

This product contains no inactive ingredients




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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
EPSOM SALT  SOAKING SOLUTION
magnesium sulfate granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51345-099
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE2.72 kg  in 2.72 kg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51345-099-012.72 kg in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/13/2012
Labeler - Advanced Beauty Systems, Inc. (129986613)
Registrant - Giles Chemical, a division of Premier Magnesia, LLC (003162435)
Establishment
NameAddressID/FEIBusiness Operations
Giles Chemical, a division of Premier Magnesia, LLC003162435manufacture

Revised: 6/2012
Document Id: 2cda2490-12e0-4b87-8c8e-7e7807bf5aa4
Set id: c93e2a1d-0fc4-4dc7-b253-9a9fe1a62151
Version: 1
Effective Time: 20120620
 
Advanced Beauty Systems, Inc.