PAIN FREEZE ROLL-ON COLD THERAPY PAIN RELIEF- menthol liquid

Pain Freeze Roll-on Cold Therapy Pain Relief by

Drug Labeling and Warnings

Pain Freeze Roll-on Cold Therapy Pain Relief by is a Otc medication manufactured, distributed, or labeled by Blue Cross Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

Menthol 6% Topical analgesic

PURPOSE

Uses: Provides soothing cold to sore muscles and joints

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for childen 5 years or younger.

INDICATIONS & USAGE

Ask a doctor before using before use if pregnant or breast feeding. Consult a doctor and discontinue use if irritation occurs.

WARNINGS

Warnings:

For external use only. Avoid contact with eyes, mucous membranes or broken skin.

When using this product, do not: heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucous membrane, take by mouth or place in nostrils, apply to wounds or damaged skin. Do not use other than as directed.

DOSAGE & ADMINISTRATION

Directions: Apply liberally to area of pain and massage until lotion is absorbed into the skin

INACTIVE INGREDIENT

Inactive Ingredients: Water, Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf Extract, Calendula Officinalis Extract, Arctium Lappa (Burdock) Root Extract, Ilex Paragariensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis (Green Tea) Leaf Extract, Melissa Officinalis (Lemon Balm) Leaf Extract, Camphor, Isopropyl Myristate, Carbomer, Triethanolamine, Silicon Dioxide, Tocopheryl (Vitamin E) Acetate.

PRINCIPAL DISPLAY PANEL

Muscle and Fitness

CBD Pain Freeze

Roll-on

Cold Therapy Pain Relief

3 Fl Oz (89mL)

INGREDIENTS AND APPEARANCE

PAIN FREEZE ROLL-ON COLD THERAPY PAIN RELIEF 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22431-289
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR, (-)- (UNII: 213N3S8275)
CARBOMER 934 (UNII: Z135WT9208)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FRANKINCENSE (UNII: R9XLF1R1WM)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22431-289-01	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/06/2019

Labeler - Blue Cross Laboratories, Inc (008298879)

Registrant - Blue Cross Laboratories, Inc (008298879)

Establishment
Name	Address	ID/FEI	Business Operations
Blue Cross Laboratories, Inc		008298879	manufacture(22431-289)