FDA.reportPublic FDA data

Rhuli Gel

Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:47:27

Label at a glance#

ProductRhuli Gel
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure13 sections

Indications and 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

Dosage and administration

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

Storage and handling

Store at controlled room temperature 20°-25°C (68°-77°F). Close cap tightly after use Questions: Call 1-888-296-9067

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor 0.3%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.3%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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:

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again with a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • 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:

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 20°-25°C (68°-77°F).
  • Close cap tightly after use

Questions: Call 1-888-296-9067

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • Benzyl alcohol, Carbomer 940, Isopropyl alcohol, Purified water, Trolamine

Distributed By:

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA, LLC.

101 NE Third Ave. Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

rhuli gel 2rhuli gel 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244443camphor 0.3 % / menthol 0.3 % Topical GelPSN6
1923146Rhuli Gel 0.3 % / 0.3 % Topical GelPSN6
1923146camphor 0.003 MG/MG / menthol 0.003 MG/MG Topical Gel [Rhuli]SBD6
244443camphor 0.003 MG/MG / menthol 0.003 MG/MG Topical GelSCD6
244443camphor 0.3 % / menthol 0.3 % Topical GelSY6
1923146Rhuli (camphor 0.3 % / Menthol 0.3 % ) Topical GelSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-031-20Rhuli Gel1 in 1 BOXGEL16
69396-031-20Rhuli Gel85 g in 1 TUBEGEL856

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-031RHULI GEL (CAMPHOR, MENTHOL) GEL [TRIFECTA PHARMACEUTICALS USA, LLC.]6Current NDC, Legacy NDC, 2 package rows20241222_4fbb3c23-ed47-336e-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-031-20GM - Gram69396-0319b2aff52-fea7-44fa-94a9-e09420894cef12019-04-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-03169396-031-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
CARBOMER 9404Q93RCW27EIACT
ISOPROPYL ALCOHOLND2M416302IACT
MENTHOLL7T10EIP3AACTIB
BENZYL ALCOHOLLKG8494WBHIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rhuli GelCAMPHOR, MENTHOLTrifecta Pharmaceuticals USA, LLC.4fbb3c23-ed47-336e-e054-00144ff8d46c2024-12-20WarningsExact identifier
ndc (package): 69396-031-20
ndc (product): 69396-031
ndc11 (package): 69396003120
spl id: 29b3b3a6-1e3f-3efa-e063-6294a90a15c2
spl set id: 4fbb3c23-ed47-336e-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.