cold leaf nutrition inc

cold leaf nutrition inc.
SPL v1
SPL
SPL Set ID 9fcc79e6-8176-4ebc-8602-0649b02fab86
Route
topical
Published
Effective Date 2018-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (37 mg)
Inactive Ingredients
aloe vera leaf arnica montana camphor (synthetic) carbomer homopolymer type c (allyl pentaerythritol crosslinked) ilex paraguariensis leaf isopropyl alcohol phenoxyethanol tea tree oil .alpha.-tocopherol acetate water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2018-09-27

Purpose

TOPICAL ANALGESIC

Description

NATURAL Menthol USP 3.7%


Medication Information

Purpose

TOPICAL ANALGESIC

Description

NATURAL Menthol USP 3.7%

*uses:

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

Other:

Store in cool dry area - close cap tight

Section 50565-1
  • KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN.
  • Accidental ingestion: Seek professional help and contact Poison Control immediately.
Section 50570-1
  • 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.
Section 53414-9
  • Pregnancy - Breast Feeding Warning:
  • If pregnant or breast feeding, ask a physician before use.
Purpose:

TOPICAL ANALGESIC

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
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
Active Ingredients

NATURAL Menthol USP 3.7%

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)


Structured Label Content

*uses: (*USES:)

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

Other: (OTHER:)

Store in cool dry area - close cap tight

Section 50565-1 (50565-1)
  • KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN.
  • Accidental ingestion: Seek professional help and contact Poison Control immediately.
Section 50570-1 (50570-1)
  • 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.
Section 53414-9 (53414-9)
  • Pregnancy - Breast Feeding Warning:
  • If pregnant or breast feeding, ask a physician before use.
Purpose: (PURPOSE:)

TOPICAL ANALGESIC

Warnings: (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
Directions: (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
Active Ingredients (ACTIVE INGREDIENTS)

NATURAL Menthol USP 3.7%

Inactive Ingredients: (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 (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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)