RAGING KAKAPO PAIN RELIEVE- capsaisin and histamine dihydrochloride cream 
EffiHealth LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Raging Kakapo™ Pain Relieve Cream

Drug Facts

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

Uses

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

Warnings

For external use only

When using this product

  • 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

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

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

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

Directions

Adults and children over 18 years

  • 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

Ask a doctor

Other information

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

Inactive ingredients

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?

1-888-435-3108

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

PRINCIPAL DISPLAY PANEL - 113.4 g Jar Carton

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
RAGING KAKAPO PAIN RELIEVE 
capsaisin and histamine dihydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70984-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 g
histamine dihydrochloride (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) histamine dihydrochloride0.75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Emu Oil (UNII: 344821WD61)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Eucalyptus Oil (UNII: 2R04ONI662)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
Niacinamide (UNII: 25X51I8RD4)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
Steareth-21 (UNII: 53J3F32P58)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
ARNICA MONTANA (UNII: O80TY208ZW)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Glucosamine Sulfate (UNII: 1FW7WLR731)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV)  
Steareth-2 (UNII: V56DFE46J5)  
Sodium Hydroxide (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Methylisothiazolinone (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70984-001-011 in 1 CARTON10/25/2017
1113.4 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/25/2017
Labeler - EffiHealth LLC (080382011)

Revised: 10/2017
Document Id: b88fb921-dd26-4b22-88be-a7c0d5577636
Set id: df302168-163d-44c6-b0d7-216c1f727dbd
Version: 1
Effective Time: 20171030
 
EffiHealth LLC