Active Ingredient
Camphor 0.3%
Menthol 0.3%
Rhuli Gel
FDA Label NDC 69396-031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa, Llc. for the product Rhuli Gel (NDC 69396-031). 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 active ingredient, purpose, uses, warnings, stop use and ask doctor if:, keep out of reach of children, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Topical Analgesic
Uses
Temporarily relieves pain and itching associated with:
- minor burns
- scrapes
- sunburn
- insect bites
- minor cuts
- minor skin irritations
- rashes due to poison ivy, poison oak, poison sumac
Warnings
For external use only
Flammable: Keep away from fire or flame
When using this product: avoid contact with eyes
Stop Use And Ask Doctor If:
- Condition worsens
- Symptoms last more than 7 days or clear up and occur again with a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions:
- Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
- Children under 2 years of age: ask a doctor
Other Information:
- Store at controlled room temperature 20°-25°C (68°-77°F).
- Close cap tightly after use
Questions: Call 1-888-296-9067
Inactive Ingredients
- Benzyl alcohol, Carbomer 940, Isopropyl alcohol, Purified water, Trolamine
Distributed By:
Trifecta Pharmaceuticals USA, LLC.
101 NE Third Ave. Suite 1500
Ft. Lauderdale, FL. 33301 USA
www.trifecta-pharma.com
* Please review the disclaimer below.
