EPSOM SALT BABY BEAUTY- magnesium sulfate, unspecified granule 
Click Products LLC

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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Magnesium Sullfate USP (Epsom Salt)

Internal Use ...............Saline laxative

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

For internal Use as laxative:

USES

Internal

External - RElieves pain from minor prains and bruises

KEEP OUT OF REACH OF CHILDREN. Where prompt relief is not obtained or where ther is evidence of infection, discontinue use and consult a physician. Hot or warm soaks should not be used by individuals with diabetes except on advice of a physician. Avoid contact with eyes.

Warnings - Ask a doctor before use if you have:

Ask doctor or pharmacist before use if you are presently taking any other drug. take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product, do not use more than directed.

Stop and consult a doctor if:

As a soaking solution if:

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

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

EPSOM SALT WITHOUT SCENT CAN BE APPLIED FOR BOTH INTERNAL AND EXTERNAL USE, SCENTED EPSOM SALT CAN BE APPLIED FOR EXTERNAL USE ONLY.

n/a

label

EPSOM SALT  BABY BEAUTY
magnesium sulfate, unspecified granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71611-010
Route of AdministrationORAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED100 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71611-010-02907 g in 1 BOX; Type 0: Not a Combination Product10/19/2017
2NDC:71611-010-031361 g in 1 BAG; Type 0: Not a Combination Product10/19/2017
3NDC:71611-010-01454 g in 1 BAG; Type 0: Not a Combination Product10/19/2017
4NDC:71611-010-041814 g in 1 BAG; Type 0: Not a Combination Product10/19/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/19/2017
Labeler - Click Products LLC (080766174)
Establishment
NameAddressID/FEIBusiness Operations
PRIYAL COSMETICS675482356manufacture(71611-010)

Revised: 3/2020
Document Id: a18c783b-9e9a-066b-e053-2995a90a1887
Set id: 5beb2c85-4ff9-b5c0-e053-2991aa0a367b
Version: 2
Effective Time: 20200323
 
Click Products LLC