ONE GEL SPORT  PAIN RELIEVING- camphor (synthetic) and menthol gel 
Phyto Creativ

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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One Gel Sport
Pain relieving gel

Phyto Creativ Drug Facts

Active IngredientsPurpose
Camphor 3%Pain Reliever
Menthol 2.2%Pain Reliever

Uses

For the temporary relief of minor aches and pains of muscles and joints

Warnings

For external use only

Do not use on wounds, damaged skin or irritated areas a heating pad on treated area

When using this product use only as directed avoid contact with eyes and mucous membranes do not bandage tightly

Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days conditions clear up and occur again within a few days.

If pregnant or breast-feeding ask a healthcare professional before use.

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

Directions

Adults and Children 7 years of age and older: apply to the affected area up to 3 times daily, as needed.

Inactive Ingredients

Alcohol, carbomer, equisetum arvense extract, FD&C Blue No. 1, limonene, linalool, malaleuca leucadendron cajaput oil, potassium sorbate, PPG-1-PEG-9 lauryl glycol esther, rosmarinus officinals malaleuca, sodium benzoate, sodium hydroxide, thymus vulgaris, water.

Distributed by One Gel USA Inc.
Lighthouse Point, FL 33064

PRINCIPAL DISPLAY PANEL - 100 ml Bottle Label

one gel Sport

TWIST CAP TO OPEN

Laboratoires
Phyto
Creativ

USA

Paraben free
Phenoxyethanol free
Essential oils

①™
one gel
Sport

Pain Relieving Gel

NET WT : 3.38 oz. (100 ml)

Principal Display Panel - 100 ml Bottle Label
ONE GEL SPORT   PAIN RELIEVING
camphor (synthetic) and menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69023-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic)30 mg  in 1 mL
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol22 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
equisetum arvense branch (UNII: 1L0VKZ185E)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
linalool, (+/-)- (UNII: D81QY6I88E)  
potassium sorbate (UNII: 1VPU26JZZ4)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium hydroxide (UNII: 55X04QC32I)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69023-100-30100 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34807/04/2014
Labeler - Phyto Creativ (263842260)
Establishment
NameAddressID/FEIBusiness Operations
Phyto Creativ263842260MANUFACTURE(69023-100)

Revised: 8/2014
Document Id: 5ac0eadd-ce2d-47df-9f86-9513defd288e
Set id: 04d9d757-6c99-480c-bab3-eb38ab1992a4
Version: 1
Effective Time: 20140822
 
Phyto Creativ