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  5. Label Information: Sports Balm

FDA Label for Sports Balm

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. DOSAGE & ADMINISTRATION
    6. WARNINGS
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sports Balm Product Label

The following document was submitted to the FDA by the labeler of this product Dr.sankunni's Ayurvedic Research Foundation Private Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

all natural relief balm coconut 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

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


* Please review the disclaimer below.