PAIN RELIEF (menthol, unspecified form, methyl salicylate, and camphor- synthetic patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)

Available from:

Unexo Life Sciences, Private Limited

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For temporary relief of minor aches and pains of muscles and joints associated with: Simple backache | Arthritis | Sprains | Strains | Bruises

Authorization status:

OTC monograph not final

Summary of Product characteristics

PAIN RELIEF- MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND CAMPHOR
(SYNTHETIC) PATCH
UNEXO LIFE SCIENCES, PRIVATE LIMITED
_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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PAIN RELIEF
_DRUG FACTS_
_ACTIVE INGREDIENT_
_PURPOSE_
Menthol 7%
Topical
Analgesic
Wintergreen Oil 7%
Topical
Analgesic
Camphor 7%
Topical
Analgesic
US ES
For temporary relief of minor aches and pains of muscles and joints
associated with: Simple backache |
Arthritis | Sprains | Strains | Bruises
WARNINGS
FOR EXTERNAL USE ONLY.
DO NOT USE OTHERWISE THAN AS DIRECTED.
DO NOT USE
On open wounds, cuts, eyes and face
With a heating pad
WHEN USING THIS PRODUCT
Avoid contact with eyes and mucous membranes
Do not bandage tightly
ASK YOUR DOCTOR BEFORE USE IF YOU HAVE
redness over the affected area
have sensitive skin
are pregnant or breast-feeding
STOP USE AND ASK YOUR DOCTOR
If condition worsens or if symptoms persist for more than 7 days or
clear up and occur again within
a few days
If abnormal skin irritation occurs after usage
KEEP OUT OF REACH OF CHILDREN.
If swallowed, seek medical help or contact a Poison Control Center
right away
DIRECTIONS
For use by Adults and Children 12 years of age and older
Apply to the affected area no more than 2 times a day
Dry skin completely at application area, before applying the patch
Open pouch and remove patch
Peel of protective film and apply sticky side to affected area
If applied on hairy skin, remove gently using mild warm water
Patch once used, cannot be re-pasted or reused
Dispose properly after use
Children under 12 years of age, consult a doctor
OTHER INFORMATION
Store at room temperature below 80°F (27°C)
INACTIVE INGREDIENTS
Adhesive Plaster
MANUFACTURED BY:
UNEXO LIFE SCIENCES PVT. LTD.
B-16, SECTOR 4, BAWANA INDUSTRIAL AREA,
DELHI -110039 (INDIA)
PRINCIPAL DISPLAY PANEL - 3 PATCH POUCH
NDC: 71391-135-03
unexo
LIFE SCIENCES
PAIN