REACTICE REACTIVATING ICE BAUME- menthol cream 
Rejuventus, 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.

----------

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.





image of back label



Reactice

Reactivating Ice Baume

external analgesic

16 fl oz./473ml






image of front label

REACTICE  REACTIVATING ICE BAUME
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75963-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL118.29 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
CLOVE (UNII: K48IKT5321)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GLYCINE (UNII: TE7660XO1C)  
JOJOBA OIL (UNII: 724GKU717M)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Rwm Technologies003215779manufacture

Revised: 1/2012
Document Id: f413f3df-ff3e-4640-8f84-d13f951ab746
Set id: 9d9cf361-49ce-4b0d-a061-24330d319170
Version: 3
Effective Time: 20120127
 
Rejuventus, Inc.