EXTRA STRENGTH HUA TUO PAIN RELIEF- camphor and menthol patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

Available from:

MADISON ONE ACME INC

Administration route:

TRANSDERMAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose External Analgesic External Analgesic Uses For the temporary relief of minor aches and pains of muscles and joints due to: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains Do not use ■ on irritated or damaged skin ■ on wounds ■ if you are allergic to any ingredient in this product Stop use and ask a doctor if ■ condition worsens ■ symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ excessive irritation of the skin develops ■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs ■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation) ■ when using for pain of arthritis:    ■ pain persists for more than 10 days    ■ redness is present    ■ in conditions affecting children under 12 years of age

Authorization status:

OTC monograph not final

Summary of Product characteristics

EXTRA STRENGTH HUA TUO PAIN RELIEF- CAMPHOR AND MENTHOL PATCH
MADISON ONE ACME INC
_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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DRUG FACTS
_ACTIVE INGREDIENTS_
Camphor 3.1%
Menthol 2.6%
_PURPOSE_
External Analgesic
External Analgesic
_USES_
For the temporary relief of minor aches and pains of muscles and
joints due to:
■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains
_WARNINGS_
FOR EXTERNAL USE ONLY
ALLERGY ALERT: This product contains natural rubber latex which may
cause allergic reactions.
DO NOT USE■ on irritated or damaged skin
■ on wounds
■ if you are allergic to any ingredient in this product
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU HAVE
■ any concerns about using this product
WHEN USING THIS PRODUCT
■ avoid contact with the eyes or mucous membranes
■ do not bandage tightly
■ do not apply heat to the area in the form of heating pads, hot
water bottles, or lamps (doing so
increases the risk of serious burns)
■ avoid placing on extremely hairy areas of skin to avoid irritation
upon removing the patch
STOP USE AND ASK A DOCTOR IF
■ condition worsens
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ excessive irritation of the skin develops
■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash
occurs
■ you feel actual pain or experience blistering or burning after
application (it is normal to feel a
warming or cooling sensation)
■ when using for pain of arthritis:
■ pain persists for more than 10 days
■ redness is present
■ in conditions affecting children under 12 years of age
REPORT ANY UNEXPECTED SIDE EFFECTS from the use of this product to the
FDA MedWatch Program.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
_DIRECTIONS_
■ adults and children 2 years of a