GEL COOLING PAIN RELIEF- menthol gel

Gel Cooling Pain Relief by

Drug Labeling and Warnings

Gel Cooling Pain Relief by is a Otc medication manufactured, distributed, or labeled by Kroger, Vi Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingrident

Menthol 4%

Purpose

External analgesic

Use

for temporary relief from minor aches and pains of muscles & joints associated with

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only

Flammable, keep away from fire or flame.

When using this product

• avoid contact with the eyes
• do not apply to wounds or damaged skin
• do not bandage tightly

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: consult a doctor

Other information

store in a cool dry place with lid closed tightly

Inactive ingredients

Aloe barbadensis leaf juice, Arctium lappa root extract, Arnica montana flower extract, blue 1, Boswellia carterii resin extract, Calendula officinalis flower extract, Camellia sinensis leaf extract, camphor, carbomer, Chamomilla recutita (matricaria) flower extract, glycerin, Ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, tocopheryl acetate, triethanolamine, water, yellow 5

Adverse Reactions Section

Biofreeze is a registered trademark of Biofreeze Performance Health, Cuyahoga Falls, OH Biofreeze Performance Heath is not affilated with The Kroger Co. or this product.

DISTRIBUTED BY

THE KROGER CO.

CINCINNATI, OHIO 415202

QUALITY GUARANTEE

800-632-6900

www.kroger.com

principal display panel

COMPARE TO the active igredient in BIOFREEZE PAIN RELIEF GET

Kroger

Cooling

Therapy

Relief

Pain Relieving Gel

Cold Pain Relief Therapy

Fast Acting Menthol Pain Relief

Provides Temporary Relief from

Sore Muscles, Joints, Sprains,

Strains & Bruises

3 FL OZ (89 mL)

INGREDIENTS AND APPEARANCE

GEL COOLING PAIN RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	160 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CHAMOMILE (UNII: FGL3685T2X)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
JUNIPER BERRY (UNII: O84B5194RL)
MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
water (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-043-21	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/15/2020
2	NDC: 30142-043-18	74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	02/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/15/2020

Labeler - Kroger (006999528)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(30142-043)