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  5. Label Information: Menthol 5% Hydrogel

FDA Label for Menthol 5% Hydrogel

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND CONSULT A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRINCIPAL DISPLAY PANEL - 5 PATCH POUCH CARTON

Menthol 5% Hydrogel Product Label

The following document was submitted to the FDA by the labeler of this product Unexo Life Sciences, Private Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Manufactured in India By:
Unexo Life Sciences Pvt. Ltd.
B-16, Sector 4, Bawana Industrial Area,
Delhi - 110039 (INDIA)


Active Ingredient



Menthol 5%


Purpose



Topical Analgesic


Use



For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps


Warnings



For external use only


When Using This Product



  • Use only as directed
  • Rare cases of serious burns have been reported with products of this type
  • Don't bandage tightly or use with a heating pad
  • Avoid contact with eyes or mucous membranes
  • Don't apply to wounds or damaged skin
  • Do not use at the same time as other topical analgesics

Stop Use And Consult A Doctor If



  • Condition worsens
  • redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • You experience signs of skin injury such as pain, swelling, or blistering where the product was applied.

Otc - Pregnancy Or Breast Feeding



If pregnant of breastfeeding, ask a health professional before use


Otc - Keep Out Of Reach Of Children



Keep Out of Reach of Children. Do not use on infants. If swallowed, seek medical help or contact a Poison Control Centre right away.


Directions



  • Adults and children 12 years of age and over: Carefully remove backing from patch. Applu sticky side of patch to affected area. Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age consult a physician.

Other Information



Store at room temperature below 86°F (30°C)


Inactive Ingredients



acrylates copolymer, alcohol, carboxymethylcellulose sodium, edetate Disodium, dihydroxyaluminium aminoacetate, glycerine, kaolin, methylparaben, polysorbate 80, polyvinyl alcohol, propylparaben, PVP, sodium polyacrylate, sorbitan oleate, sorbitol, tartaric Acid, titanium Dioxide, water


Principal Display Panel - 5 Patch Pouch Carton



NDC 71391-127-05

UNEXO'S MENTHOL 5%
HYDROGEL PATCH

5% Menthol

BACK & LARGE AREAS

Targeted, Long-Lasting
Pain Relief

TOPICAL ANALGESIC

* Please review the disclaimer below.