Cold Leaf Nutrition Muscle And Joint Pain Relief Gel
FDA Label NDC 66902-114

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Essentials, Inc. for the product Cold Leaf Nutrition Muscle And Joint Pain Relief (NDC 66902-114). 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:, otc - pregnancy or breast feeding, otc - do not use, otc - keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

NATURAL Menthol USP 3.7%

Purpose:

TOPICAL ANALGESIC

*Uses:

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings:

Use only as directed.

  • For external use only
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
  • Avoid contact with eyes or mucous membranes

Otc - Pregnancy Or Breast Feeding

  • Pregnancy - Breast Feeding Warning:
  • If pregnant or breast feeding, ask a physician before use.

Otc - Do Not Use

  • Do not use with other topical products
  • Do not use with heating devices
  • Do not use on open wounds, damaged or irritated skin
  • Keep away from excessive heat or open flame.

Otc - Keep Out Of Reach Of Children

  • KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN.
  • Accidental ingestion: Seek professional help and contact Poison Control immediately.

Directions:

Adults and children 12 years and older

  • Apply and gently massage painful joints and/or muscles.
  • Repeat as needed no more than 4 times a day.
  • Wash hands after each use with cold water

Other:

Store in cool dry area - close cap tight

Inactive Ingredients:

†Aloe Barbadensis Leaf Extract, †Arnica Montana Extract, Camphor, Carbomer, Ethylhexylglycerin, †llex Paraguariensis Leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Water.

†This symbol before the ingredient indicates certified organic:

Principal Display Panel - Cold Leaf Nutrition Container Label

MUSCLE & JOINT PAIN RELIEF*

Leaf Cold Nutrition

ALOE AND ARNICA, VITAMIN E AND TEA TREE OIL
GREASELESS • VANISHING SCENT • ROLL ON FORMULA

NO PARABENS • NO SYNTHETIC FRAGRANCE • NO SULFATES
NO PARAFFINS • NO DEA • NO PETROLATUM • NO MINERAL OIL
• NO ANIMAL TESTING

89 mL (3 fl oz)

Principal Display Panel (Cold Leaf Nutrition Container Label)

Principal Display Panel (Cold Leaf Nutrition Container Label)

* Please review the disclaimer below.