Womens Relief Balm
FDA Label NDC 70146-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr.sankunni's Ayurvedic Research Foundation Private Limited for the product Womens Relief Balm (NDC 70146-001). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients   Purpose

Camphor 11%                                           Topical Analgesic

Eucalyptus Oil 10%                                    Anti-Inflammatory

Menthol 8%                                               Topical Analgesic

Wintergreen Oil (Methyl Salicylate) 10%     Topical Analgesic

Otc - Purpose

Uses:  Temporarily relieves minor aches & pains related to

  • arthritis
  • backaches
  • bursitis
  • sore muscles
  • joint pain
  • leg cramps
  • bruises
  • sprains

Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a poison control center immediately.

Indications & Usage

ZEN

for aches & pains

women's relief balm jasmine oil

ideal for:

aches & pains related to

rheumatoid arthritis

joint pain

backaches

bursitis

sore muscles

arthritis

leg cramps

sprains and strains

Dosage & Administration

Directions:

  • use only as directed
  • apply generously to affected area 3 to 4 times daily
  • children under 12, consult a doctor before use.

Warnings

WARNINGS For external use only

When using this product

  • discontinue use if excessive irritation of the skin develops
  • avoid contact with eyes and mucus membranes
  • do not bandage tightly
  • do not use with heating pad

    • Stop use and ask a doctor if

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

Inactive Ingredient

Inactive Ingredients

paraffin wax, white petroleum jelly, light liquid paraffin, beeswax, clove oil, nutmeg oil, cassia oil, cinnamon oil, peppermint oil, borneol, citronella oil, jasmine oil

* Please review the disclaimer below.