ENOKON PAIN RELIEF PATCH- pain relief patch patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X)

Available from:

Henan Enokon Medical Instrument Co Ltd.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical analgesic Temporarily relieves minor pain associated with: arthritis, simple backache, muscle strains, bruises If you feel unwell, please deal with it in time

Authorization status:

OTC monograph final

Summary of Product characteristics

ENOKON PAIN RELIEF PATCH- PAIN RELIEF PATCH PATCH
HENAN ENOKON MEDICAL INSTRUMENT CO LTD.
_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._
----------
ACTIVE INGREDIENT
Borneol 1%
PURPOSE
Topical analgesic
USE
Temporarily relieves minor pain associated with: arthritis, simple
backache, muscle
strains, bruises
WARNINGS
For externaluse only Keep out ofreach of children Pregnant,
breast-feeding, people with
severe chronicdiseases or allergic to the raw materials are forbidden
to use
DO NOT USE
If you feel unwell, please deal with it in time
WHEN USING
Use only as directed
Do not bandage tightly or use with a heating pad Avoid contact with
eyes or mucous
membranes
Do not apply to wounds or damaged skin
STOP USE
ASK DOCTOR
Condition worsen
Symptoms persist more than 7 days or clear up and occur again within a
few days
Skin irritation develops
KEEP OOT OF REACH OF CHILDREN
Do not leave the product within reach of unconscious persons.
DIRECTIONS
Adults and children 12 years of age and older: apply to affected area
no more than 12
hours per timeChildren under 12 vear ofage: consult a doctorPeel off
back protective
film and alian the stainless steel ball with the affected area and
apply patch,
pressingpatch to skin for secure adhesion
OTHER INFORMATION
Store the product in a cool, dry and well-ventilated placeAvoid direct
sunlight
INACTIVE INGREDIENTS
Camphor (Synthetic), Menthol,Capsaicin,Chuanxiong Rhizoma, Cinnamon,
Paeonia
LactifloraRoot,Caryophyli Flos, Lycopodii Herba, Carthami Flos,
Olibanum, Myrrha,
Notopteryqii RhizomaEt Radix,Achyranthis Bidentatae Radix
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
ENOKON PAIN RELIEF PATCH
pain relief patch patch
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:83559-002
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BORNEOL (UNII: M89NIB437X) (B