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XtraCare Ice Cold Topical Analgesic Gel

Medically reviewed on February 27, 2017

Dosage form: gel
Ingredients: MENTHOL 3g in 227g
Labeler: Rejoice International
NDC Code: 57337-052

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.

Active Ingredients:                                 Purpose

Menthol 1.25% ........................... Topical Analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

XtraCare® Ice Cold Topical Analgesic Gel

Net Wt 8 oz (227 g)

Warnings

For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with

  • smoking
  • excessive phlegm
  • asthma
  • emphysema
  • persistent or chronic cough

When using this product do not

  • heat
  • microwave
  • add to hot water or any container where heating water may cause splattering and result in burns
  • use in eyes or directly on mucous membranes
  • take by mouth or place in nostrils
  • apply to wounds or damaged skin
  • bandage skin

Consult a doctor and discontinue use if condition worsens, persists for more than 1 week or tends to recur.

Directions

  • see important warnings under "When using this product"
  • adults & children 2 years of age & older: apply to the affected area not more than 3 to 4 times daily.
  • children under 2 years of age: consult a physician

Inactive Ingredients:

camphor, carbomer, ethyl alcohol, FD&C blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

Other information: store at 20o to 25oC (68o to 77oF)

Questions/Comments? 1-855-345-5575

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168 USA

MADE IN CHINA

XTRACARE ICE COLD TOPICAL ANALGESIC GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-052
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL3 g  in 227 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (NATURAL) 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
ALCOHOL 
FD&C BLUE NO. 1 
ISOPROPYL ALCOHOL 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:57337-052-01227 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/30/2014
Labeler - Rejoice International (078741245)
Establishment
NameAddressID/FEIOperations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(57337-052)

 
Rejoice International

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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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