XTRACARE ICE COLD TOPICAL ANALGESIC GEL- menthol gel 
China Ningbo Shangge Cosmetic Technology Corp

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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XtraCare Ice Cold Topical Analgesic Gel

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

When using this product do not

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

Directions

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

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XTRACARE ICE COLD TOPICAL ANALGESIC GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 227 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58503-052-01227 g in 1 BOTTLE; Type 0: Not a Combination Product01/30/2014
2NDC:58503-052-02227 g in 1 TUBE; Type 0: Not a Combination Product01/30/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/30/2014
Labeler - China Ningbo Shangge Cosmetic Technology Corp (529287434)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-052)

Revised: 8/2018
Document Id: 72c50c9b-c877-2e62-e053-2a91aa0a7785
Set id: a76f6abe-37cf-459f-96e3-7dd60b6d5723
Version: 5
Effective Time: 20180806
 
China Ningbo Shangge Cosmetic Technology Corp