Reactice Reactivating Ice Baume

Dosage form: cream
Ingredients: MENTHOL 118.29mL in 100mL
Labeler: Rejuventus, Inc.
NDC Code: 75963-125

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.

Reactice Reactivating Ice Baume

Active ingredients              Purpose

Menthol (5%)                   External Analgesic        

Uses

For temporary relief of minor aches and pains of muscles such as: simple backache, lumbago, arthritis, neuralgia, strains, bruises, strains, bruises,  and sprains

Keep out of reach of children

Consult a doctor and discontinue use if conditions worsen or persist for more than 7 days.

For External use only. When using this product avoid contact with eyes. Wash hands completely after each use. If swallowed seek medical assistance immediately or contact poison control. If you are pregnant or nursing,seek the advice of your doctor before using this product.

Directions for use


Apply cream to sore muscles and joints and massage into skin as needed. For adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a doctor.

Water, Dimethyl Sulfone, Clove bud oil, Peppermint oil, Eucalyptus oil, Aloe Vera, Ascorbic acid, Tocopherol, Glycine, Wintergreen oil, Jojoba oil, Arnica Montana  Flower Extract, Polyacrylamide, C13-14 Isoparaffin, Laureth 7, Sodium Hydroxymethylglycinate, glycerol.








Reactice

Reactivating Ice Baume

external analgesic

16 fl oz./473ml







REACTICE  REACTIVATING ICE BAUME
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75963-125
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL118.29 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHYL SULFONE 
CLOVE 
PEPPERMINT OIL 
EUCALYPTUS OIL 
ALOE VERA LEAF 
ASCORBIC ACID 
TOCOPHEROL 
GLYCINE 
JOJOBA OIL 
ARNICA MONTANA FLOWER 
C13-14 ISOPARAFFIN 
LAURETH-7 
SODIUM HYDROXYMETHYLGLYCINATE 
GLYCERIN 
Packaging
#Item CodePackage Description
1NDC:75963-125-01118.29 mL in 1 JAR
2NDC:75963-125-02473 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/21/2011
Labeler - Rejuventus, Inc. (032186703)
Registrant - Rejuventus, Inc. (032186703)
Establishment
NameAddressID/FEIOperations
Rwm Technologies003215779manufacture

Revised: 01/2012
 
Rejuventus, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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