Mata Balm
FDA Label NDC 58167-112

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amata Llc for the product Mata Balm (NDC 58167-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Camphor 4.5%

Menthol 37%

Purpose

Topical  Analgesic 

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

For temporarily relief of pain and itching associated with insect bites,minor skin irritations and infections,

rashes, boils, minor aches and pains of muscles and joints, dizziness

Warnings

For external use only

When using this product

  • Use only as directed
  • Do not apply to wounds and broken skin
  • Avoid contact with eyes

    • Stop use and ask a doctor if

    • condition worsens
    • severe skin irritation occurs
    • symptoms persist for more than 7 days or clear up and reoccur within a few days

Directions


Apply thin layer to or rub gently upon the desired area or inhale as needed. Repeat 3 to 4 times daily. For infants under 12 months of age, consult physician before use


Inactive Ingredients


Aloe Vera, Barleria Lupulina, Beach Morning Glory, Betel leaf, Clinacanthus Nutans Lindau, Coconut oil, Crinum Veld Lily, Garden Quinine, Paraffin, Petrolatum,Zingiber Cassamunar.


Storage And Handling


Other Information:

This product may cause allergic reaction in some individuals, test on small area before use

Store at 68° to 85°F (20° to 30°C)


Package Label.Principal Display Panel

Drug Label (Mata)

Drug Label (Mata)

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