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

One Gel Sport by

Drug Labeling and Warnings

One Gel Sport by is a Otc medication manufactured, distributed, or labeled by Phyto Creativ. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Phyto Creativ Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
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.

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69023-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET)	Camphor (Synthetic)	30 mg  in 1 mL
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	22 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69023-100-30	100 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	07/04/2014

Labeler - Phyto Creativ (263842260)

Establishment
Name	Address	ID/FEI	Business Operations
Phyto Creativ		263842260	MANUFACTURE(69023-100)