Amrutanjan Relief Pain Balm Ointment
FDA Label NDC 53554-010

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 Pain Balm (NDC 53554-010). 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 amrutanjan relief pain balmactive ingredients, purpose, uses, warningsfor external use only, when using this product, stop use 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

Amrutanjan Relief Pain Balmactive Ingredients

Camphor 10.0%

Menthol 8.0%

Methyl Salicylate 14.0%

Purpose

Camphor                           Topical analgesic

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

Warningsfor 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 add 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 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 doctor

Other Information

Store at room temperature

Inactive Ingredients

butylated hydroxy toluene, cinnamon leaf oil, citronella oil, clove oil, east indian lemongrass oil, eucalyptus oil, light mineral oil, microcrystalline wax, paraffin, petrolatum, quinoline yellow (D&C yellow no.11).

Questions?

Call 1-888-611-6811

Principal Display Panel - 30 G Jar Carton                                              Ndc 53554-010-05Amrutanjanreliefpain Balmtmpain Relieving Ointmentnet Wt: 1.05 Oz (30G)

PRINCIPAL DISPLAY PANEL - 30 g Jar Carton

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