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 Consumer Product Partners, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 4%

Purpose

External analgesic

Uses

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, llex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5

Adverse reaction

Distributed by: Consumer Product Partners, LLC

St. Louis, MO 63114

1-888-593-0593

Disclaimer

*This product is not manufactured or distributed by Reckitt Health Pain (US) LLC, distributor of BioFreeze ®Cool the Pain ®Colorless Roll-On Menthol Pain Relieving Gel.

Principal display panel

swan ®

ROLL-ON COOLING PAIN RELIEF

PAIN RELIEVING GEL

soothing menthol

• For arthritis, sore muscles, joints and back pain
• Diminishing scent

Compare to Biofreeze ®Cool the Pain ®Colorless Roll-On Menthol Pain Relieveing Gel*

2.5 FL OZ (74 mL)

INGREDIENTS AND APPEARANCE

GEL COOLING PAIN RELIEF 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-894
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 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)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-894-18	74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/13/2021

Labeler - Consumer Product Partners, LLC (119091520)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(11344-894)