REACTHEAT HEAT BAUME- menthol, capsicum annum extract cream 
Rejuventus

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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Reactheat Reactivating Heat Baume

Active Ingredients                Purpose

Menthol (5%)                       External Analgesic

Capsicum Annum Extract (0.5)     External Analgesic

Uses

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

Keep out of reach of children


Consult a doctor and discontinue use if condition worsens or persists 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, seeking 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 no 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, Polyarylamide, C13-14 Isoparaffin, Laureth 7, Sodium Hydroxymethylglycinate, glycerol.



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Reactheat
Reactivating Heat Baume

4 fl. oz./ 118.29ml






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REACTHEAT  HEAT BAUME
menthol, capsicum annum extract cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75963-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mL  in 100 mL
BIRD PEPPER (UNII: JLH5RT8O28) (BIRD PEPPER - UNII:JLH5RT8O28) BIRD PEPPER0.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
CLOVE OIL (UNII: 578389D6D0)  
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:75963-126-01118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34808/20/2011
Labeler - Rejuventus (032186703)
Registrant - Rejuventus (032186703)
Establishment
NameAddressID/FEIBusiness Operations
RWM techologies003215779manufacture

Revised: 1/2012
Document Id: e164cea7-2085-4617-a595-f90032c53ce3
Set id: a74f0c33-930c-4ff8-9e7a-2c7539b66272
Version: 3
Effective Time: 20120127
 
Rejuventus