FDA.reportPublic FDA data

Raging Kakapo™ Pain Relieve Cream

Manufacturer
EffiHealth LLC
Effective date
2017-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:51

Label at a glance#

ProductRaging Kakapo Pain Relieve
Active ingredientCAPSAICIN, histamine dihydrochloride
Label structure10 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints associated with arthritis simple backache strains bruises and sprains.

Dosage and administration

apply generously to affected area not more than 3-4 times daily massage into painful area until thoroughly absorbed wash hands with soap and water after use Ask a doctor

Storage and handling

Store between 40°F and 86°F (4°C and 30°C) do not use if protective seal on jar is torn, broken or missing upon first use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Capsaicin 0.025%Topical Analgesic
Histamine Dihydrochloride 0.075%Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with

  • arthritis
  • simple backache
  • strains
  • bruises and sprains.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly
  • do not use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds, damaged, broken or irritated skin
  • a slight burning sensation may occur upon application
  • if severe burning occurs, discontinue use
  • do not expose the treated area to heat or direct sunlight
  • do not use if allergic to capsicum or chili peppers

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • rash appears
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • irritation develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 18 years

SPL UNCLASSIFIED SECTION

  • apply generously to affected area not more than 3-4 times daily
  • massage into painful area until thoroughly absorbed
  • wash hands with soap and water after use

Children 18 years or younger

SPL UNCLASSIFIED SECTION

Ask a doctor

Other information

STORAGE AND HANDLING SECTION

Store between 40°F and 86°F (4°C and 30°C)

  • do not use if protective seal on jar is torn, broken or missing upon first use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deionized Water, Aloe Barbadensis Leaf Extract, Capric/Caprylic Triglyceride, Emu Oil, Stearic Acid, Cetyl Alcohol, Stearyl Alcohol, Eucalyptus Oil, Methylsulfonylmethane (MSM), Niacinamide, Boswellia, Steareth-21, Phenoxyethanol, Arnica Montana Extract, Sodium Hyaluronate, Green Mussel Extract, Glucosamine Sulfate, Tocopheryl Acetate, Pyridoxine Hydrochloride (Vitamin B6), Steareth-2, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Methylisothiazolinone

Questions or Comments?

OTC - QUESTIONS SECTION

1-888-435-3108

SPL UNCLASSIFIED SECTION

Distributed by:
EffiHealth Consumer Products
259 Main Street, 2nd Floor Stamford, CT 06901

PRINCIPAL DISPLAY PANEL - 113.4 g Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

Raging Kakapo™

PAIN RELIEF CREAM

Active Ingredients
Histamine Dihydrochloride & Capsaicin

Topical Analgesic
NET WT. 4 OZ. (113.4g)

Principal Display Panel - 113.4 g Jar Carton
Principal Display Panel - 113.4 g Jar Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1986870capsaicin 0.025 % / histamine dihydrochloride 0.075 % Topical CreamPSN1
1986870capsaicin 0.25 MG/ML / histamine dihydrochloride 0.75 MG/ML Topical CreamSCD1
1986870capsaicin 0.025 % / histamine dihydrochloride 0.075 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70984-001-012020-01-31C16284748780-19d75b9d0-33e5-f424-e053-dadaa90a57ceRaging Kakapo™ Pain Relieve Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70984-001-01Raging Kakapo Pain Relieve1 in 1 CARTONCREAM11
70984-001-01Raging Kakapo Pain Relieve113.4 g in 1 JARCREAM113.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70984-001RAGING KAKAPO PAIN RELIEVE (CAPSAISIN AND HISTAMINE DIHYDROCHLORIDE) CREAM [EFFIHEALTH LLC]1Legacy NDC, 2 package rows20171031_df302168-163d-44c6-b0d7-216c1f727dbd.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70984-00170984-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPSAICINS07O44R1ZMACTIB
histamine dihydrochloride3POA0Q644UACTIB
water059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
Emu Oil344821WD61IACT
Stearic Acid4ELV7Z65APIACT
Cetyl Alcohol936JST6JCNIACT
Stearyl Alcohol2KR89I4H1YIACT
Eucalyptus Oil2R04ONI662IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
Niacinamide25X51I8RD4IACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
Steareth-2153J3F32P58IACT
PhenoxyethanolHIE492ZZ3TIACT
ARNICA MONTANAO80TY208ZWIACT
HYALURONATE SODIUMYSE9PPT4THIACT
Glucosamine Sulfate1FW7WLR731IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
Pyridoxine Hydrochloride68Y4CF58BVIACT
Steareth-2V56DFE46J5IACT
Sodium Hydroxide55X04QC32IIACT
EDETATE DISODIUM7FLD91C86KIACT
Caprylyl Glycol00YIU5438UIACT
Methylisothiazolinone229D0E1QFAIACT

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
b88fb921-dd26-4b22-88be-a7c0d5577636df302168-163d-44c6-b0d7-216c1f727dbd2017-10-30WarningsExact identifier
spl id: b88fb921-dd26-4b22-88be-a7c0d5577636
spl set id: df302168-163d-44c6-b0d7-216c1f727dbd

Reported adverse events (FAERS/openFDA)#

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