CREATIONS GARDEN PAIN RELIEF ROLL ON- camphor, menthol, and methyl salicylate gel 
Creations Garden Natural Products, Inc.

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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Drug Facts

Active Ingredients

Camphor 4%
Menthol 10%
Methyl Salicylate 30%


Purpose


.……..…….............….. Topical Analgesic

...……......……….....… Topical Analgesic

.......….......… Topical Analgesic


Uses

Temporarily relieves the minor aches and  pains of muscles and joints  associated with:

Warnings

For external use only.

Do not use:


Keep out of reach of children

In case of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately.


Directions

■ Use only as directed
■ Adults and children 12 years of age and older apply
to affected area not more than 3 to 4 times daily
■ Children under 12 years of age ask a doctor


Water, Hydroxyethyl Cellulose, Edetate Disodium, Glyceryl Stearate Se,  Sorbitan Stearate, Stearic Acid,  Polysorbate 80, Potassium Hydroxide,  Phenoxyethanol (and) Caprylyl Glycol (and) Ethylhexylglycerin (and) Hexylene Glycol

Questions?

Call 1-859-422-7048

Placeholder Text

CG Pain Relief Rollon

CREATIONS GARDEN  PAIN RELIEF ROLL ON
camphor, menthol, and methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-024
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 2.96 mL  in 74 mL
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol7.4 mL  in 74 mL
Methyl Salicylate (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y) Methyl Salicylate22.2 mL  in 74 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) (UNII: ZYD53NBL45)  
Edetate Disodium (UNII: 7FLD91C86K)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Potassium Hydroxide (UNII: WZH3C48M4T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24488-024-2674 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/10/2010
Labeler - Creations Garden Natural Products, Inc. (961956229)
Registrant - Creations Garden Natural Products, Inc. (961956229)
Establishment
NameAddressID/FEIBusiness Operations
Creations Garden Natural Products, Inc. 961956229manufacture

Revised: 3/2010
Document Id: e575497a-aac0-422f-996b-e1212f617ea8
Set id: 66dd5b8d-fd7b-480f-8f45-33b6d3841abb
Version: 1
Effective Time: 20100310
 
Creations Garden Natural Products, Inc.