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Phyto Creativ Drug Facts
Distributed by One Gel USA Inc.
Lighthouse Point, FL 33064
One Gel Sport
FDA Label NDC 69023-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Phyto Creativ for the product One Gel Sport (NDC 69023-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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
Otc - Do Not Use
Do not use on wounds, damaged skin or irritated areas a heating pad on treated area
Otc - When Using
When using this product use only as directed avoid contact with eyes and mucous membranes do not bandage tightly
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding ask a healthcare professional before use.
Otc - Keep Out Of Reach Of Children
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.
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)
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