PAIN RELIEVING GEL- menthol gel

Pain Relieving Gel by

Drug Labeling and Warnings

Pain Relieving Gel by is a Otc medication manufactured, distributed, or labeled by Rite Aid, 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, Ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, tocopheryl acetate, triethanolamine, water, yellow 5

Disclaimer

*This product is not manufactured or distributed by Biofreeze Performance Health, distributor of BioFreeze ® Cool the Pain Roll-On Fast Acting Menthol Pain Relief

Adverse reaction

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE,

CAMP HILL, PA 17011

www.riteaid.com

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient of Biogreeze ® Roll-on*

ROLL-ON COOLING PAIN RELIEF

4% MENTHOL

for arthritis, sore muscles, joints & back pain

soothing menthol

diminishing scent

paraben-free

2.5 FL OZ (73 mL)

INGREDIENTS AND APPEARANCE

PAIN RELIEVING GEL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-8940
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	40 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-8940-1	74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	02/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/01/2023

Labeler - Rite Aid (014578892)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(11822-8940)