Rite Aid Cooling Pain Relief Spray, Menthol 10.5%

RITE AID COOLING PAIN RELIEF- menthol 10.5% spray
Rite Aid

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Menthol 10.5%

Topical Analgesic

For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.

For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

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

Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone, Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

Label

RITE AID COOLING PAIN RELIEF
menthol 10.5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0639
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ALCOHOL (UNII: 3K9958V90M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
JUNIPER BERRY (UNII: O84B5194RL)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11822-0639-3	85 g in 1 CAN; Type 0: Not a Combination Product	03/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/31/2021

Labeler - Rite Aid (014578892)

Registrant - Derma Care Research Labs, LLC (116817470)