Monkey Holding Peach Brand
FDA Label NDC 57373-108

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by P.s.w. Inc. for the product Monkey Holding Peach Brand (NDC 57373-108). 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 ingredients, purpose, uses, directions, inactive ingredients, warnings, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Camphor              22%

Menthol               16%

Methyl Salicylate  3%


Purpose

Topical Analgesic


Uses

For temporary relief of minor aches and pains of muscles and joints associated with over-exertion, simple backache, arthritis, strains and sprains.


Directions

  • Rub well on the affected area. Repeat 3 to 4 times daily.
  • For children 2-12 years, consult a doctor before use.

Inactive Ingredients

Paraffin, Eucalyptus Oil, Cinnamon Oil, Peppermint Oil, Olive Oil.


Warnings

For External Use Only.

When Using This Product

  • Avoid contact with eyes or mucous membranes.
  • Do not apply to open wounds or damaged skin.
  • Do not bandage or use heating pad.

Stop Use And Ask A Doctor

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persistes for more than seven days.
  • Pain clears up and then recurs a few days later

If Pregnant Or Breast-Feeding

ask a healthcare professional before use.


Keep Out Of Reach Of Children

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


Other Information

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


Principal Display Panel

Monkey Holding Peach Brand External Analgesic Balm

Export USA

Net Wt. 0.283 fl.oz. (8g)

NDC 57373-108-01

Product of Thailand


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MONKEY HOLDING PEACH BALM EXTERNAL ANALGESIC BALM

Methyl Salicylate Camphor Menthol Eucalyptus Oil

Net Wt. 0.42 fl.oz. (12g)

NDC 57373-108-02

Product of Thailand


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