Amrutanjan Relief Strong Pain Balm Ointment
FDA Label NDC 53554-020

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amrutanjan Health Care Limited for the product Amrutanjan Relief Strong Pain Balm (NDC 53554-020). 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, warnings, when using this product, stop use of this product and consult a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 15.0%

Methyl Salicylate  15%

Purpose

Menthol                    Topical analgesic

Methyl Salicylate      Topical analgesic

Uses

  • Temporarily relieves pain associated with headache, cold, body ache and nasal congestion
  • Provides temporary relief of minor pains of muscles and joints

Warnings

For External use only

  • Avoid contact with eyes
  • Do not use otherwise than as directed

When Using This Product

  • Do not heat
  • Do not microwave
  • Do not use near an open flame
  • Do not add to hot water or any container where heating water. May cause splattering and result in burns
  • Avoid contact with wounds, mucous membranes, broken or irritated skin
  • Do not bandage tightly or use with heating pad

Stop Use Of This Product And Consult A Doctor If

  • Condition worsens
  • Redness or irritation develops
  • Symptoms persist for more than 7 days or clear up and occur again within a few days or is accompanied by fever, rash, or persistent headaches

Directions

  • See important warning "When using this product"
  • Adults and children over 12 years
  • Apply and gently massage over the affected area
  • Repeat 2- 3 times daily, or as directed by a doctor
  • Children 12 years or younger: ask a doctor

Other Information

Store at room temperature

Inactive Ingredients

butylated hydroxy toluene, cetostreayl alcohol, microcrystalline wax, paraffin, petrolatum

Questions?

Call 1-888-611-6811

Ndc 53554-020-05Amrutanjan Relief Strong Pain Balmtmpain Relieving Ointmentnet Wt: 1.05 Oz (30G)

PRINCIPAL DISPLAY PANEL - 30 g Jar Carton

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