PAIN RELIEVER - menthol gel 
CA-BOTANA INTERNATIONAL

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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GREEN MARVEL MASSAGE GEL WITH HERBAL EXTRACTS.

Warnings:

For external use only.
Do not use on wounds or damaged skin
When using this product: use only as directed. Avoid contact with eyes. Do no bandage tightly
Stop use and ask a doctor if: redness is present. Irritation develops. Condition worsens or symptoms persist more than 7 days. Symptoms clear up and occur again within a few days.
Store at room temperature. Lot number and expiration date see crimp or see box.

Directions:

Adults and children over 12 year. Apply generous amount directly to affected area. Massage into painful area until thoroughly absorbed into skin. Repeat as necessary, but no more that 4 times daily.


INACTIVE INGREDIENTS:
Water. Ethanol. PPG-26 Buteth-26 (and) PEG-40. Hydrogenated Castor Oil. Acrylates/C10-30 alkyl acrylate crosspolymer. Triethanolamine. Glucosamine Sulfate. Methyl Sulfonyl Methane. (MSM). Bromelain. Harpagophytum procumbens (Devil's Claw). Hippocastanaceae aesculus hippocastanum (Horse Chestnut). Rosmarinus officinalis. Aloe barbadenis miller. Chamaemelum nobile. Capsicum annuun Extract. Tilia cordata Extract (Linden flower). Melissa officinalis. Arnica montana. Saliz alba. Eucalyptus globoulus. Tocopheryl acetate. Phenoxyethanol Ethylhexyglycerin. Potassium Sorbate. EDTA. FD and C Green # 3. FD and C Yellow # 10

Uses for temporary relief of minor aches and pains of muscles and joint associated with: simple aches, back aches, arthritis, strains, bruises, sprains.

Menthol 2% Topical analgesic

Keep out of reach of children. If swallowed get medical help or contact a Posion Control Center immediately.

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PAIN RELIEVER 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.4 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHANOL (UNII: 3K9958V90M)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
BROMELAINS (UNII: U182GP2CF3)  
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
ALOE FEROX LEAF (UNII: 0D145J8EME)  
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)  
CAPSICUM (UNII: 00UK7646FG)  
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
MELISSA OFFICINALIS (UNII: YF70189L0N)  
ARNICA MONTANA (UNII: O80TY208ZW)  
SALIX ALBA LEAF (UNII: M7S08QZ9JA)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
EDETIC ACID (UNII: 9G34HU7RV0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-002-02120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/24/2011
Labeler - CA-BOTANA INTERNATIONAL (106276728)
Registrant - RODOLFO UGELSTAD (106276728)
Establishment
NameAddressID/FEIBusiness Operations
CA-BOTANA INTERNATIONAL106276728manufacture

Revised: 8/2011
Document Id: 9e27a24a-d6dc-4d76-af32-f80588ae7b53
Set id: 2162a3d3-ce3a-4ea3-9f50-c1c8673d8dea
Version: 6
Effective Time: 20110824
 
CA-BOTANA INTERNATIONAL