Reactheat Heat Baume

Dosage form: cream
Ingredients: MENTHOL 5mL in 100mL, BIRD PEPPER 0.5mL in 100mL
Labeler: Rejuventus
NDC Code: 75963-126

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.

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.





Reactheat
Reactivating Heat Baume

4 fl. oz./ 118.29ml







REACTHEAT  HEAT BAUME
menthol, capsicum annum extract cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75963-126
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5 mL  in 100 mL
BIRD PEPPER (BIRD PEPPER) BIRD PEPPER0.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHYL SULFONE 
CLOVE OIL 
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:75963-126-01118 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/FEIOperations
RWM techologies003215779manufacture

Revised: 01/2012
 
Rejuventus

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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