WEH-WEH 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.

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Weh-Weh Capsaicin Natural Pain relief oil

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

Package label principal display

https://direct.fda.gov/apex/apex_util.get_blob_file?a=100&s=124576570469456&p=114&d=53000640981392638&i=53003644846473016&p_pk1=17118&p_pk2=Weh-Weh Oil.jpg&p_ck=A111B4F4BD5E503D93F2F34DD4E31475

WEH-WEH NATURAL PAIN RELIEF OIL 
capsaicin oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.075 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
GUGGUL (UNII: 34969JX79R)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
CURCUMA XANTHORRHIZA OIL (UNII: F8VF0V2G7H)  
HOPS OIL (UNII: 06JI9W529S)  
TEA TREE OIL (UNII: VIF565UC2G)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
SAGE OIL (UNII: U27K0H1H2O)  
GRAPEFRUIT (UNII: O82C39RR8C)  
CHAMOMILE (UNII: FGL3685T2X)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
Product Characteristics
Colorbrown (Brown -yellowish) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35192-023-0450 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/31/2016
Labeler - CA-BOTANA INTERNATIONAL (106276728)
Establishment
NameAddressID/FEIBusiness Operations
CA-BOTANA INTERNATIONAL106276728manufacture(35192-023)

Revised: 1/2021
Document Id: b8557aad-1595-b466-e053-2a95a90a5fec
Set id: 24fbb759-f04f-1a73-e054-00144ff8d46c
Version: 18
Effective Time: 20210107
 
CA-BOTANA INTERNATIONAL