OTC Medication Information: Kanjo Natural Pain Relief Oil

KANJO NATURAL PAIN RELIEF OIL- capsaicin oil
CA-BOTANA INTERNATIONAL

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.

Warning section

For external use only.
Do not use on wounds or damaged skin
When using this product: use only as directed. Avoid contact with eyes. Do no bandage tightly
Stop use and ask a doctor if: redness is present. Irritation develops. Condition worsens or symptoms persist more than 7 days. Symptoms clear up and occur again within a few days.
Store at room temperature. Lot number and expiration date see crimp or see box.

OTC — Active Ingredient

Capsaicin 0.15%

Purpose

For temporary relief of minor aches and paims of muscles and joints associated with *single aches *back aches *arthritis * strains* bruises*sprains

Keep out of reach of children. If swallowed get medical help or contact a Posion Control Center immediately.

Inactive Ingredients

Capri/ capri /tryglyceride, Chamomilla recutita (Chamomile) flower, Citrus bergamia (Bergamot) oil, Commiphora mukul (Guggul) Gum resin, Curcuma Xanthorrhiza,Eucaliptus globulus (Eucaliptus) oil,Humulus lupulus (Hop), Lavandula officinalis(Lavender) oil, Melaleuca alternifolia (Tea tree) oil, Pelargonium gravolens (Geranium) oil, Rosmarinus officinalis (Rosemary), Sage Triloba Fructicosa (Salvia triloba (Sage), Vitis vinifera (Grape seed)oil

Dosage & Administration

External topical analgesic, massage oil to the affected area not more than 4 times daily

Indications & Usage

Apply generous amont of oil directly on affected area. Massage into painful area until thoroughly absorbed into skin

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KANJO NATURAL PAIN RELIEF OIL
capsaicin oil
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35192-040
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.075 g in 50 g
Inactive Ingredients
Ingredient Name Strength
GUGGUL
EUCALYPTUS OIL
ROSEMARY OIL
CURCUMA XANTHORRHIZA OIL
HOPS OIL
TEA TREE OIL
PELARGONIUM GRAVEOLENS FLOWER OIL
SAGE OIL
GRAPEFRUIT
CHAMOMILE
MEDIUM-CHAIN TRIGLYCERIDES
BERGAMOT OIL
Product Characteristics
Color brown (Brown -yellowish) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35192-040-08 50 g in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 09/14/2020
Labeler — CA-BOTANA INTERNATIONAL (106276728)
Establishment
Name Address ID/FEI Operations
CA-BOTANA INTERNATIONAL 106276728 manufacture (35192-040)

Revised: 09/2020 CA-BOTANA INTERNATIONAL

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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