CVS HEALTH ROLL-ON FOOT PAIN RELIEF- menthol, unspecified form gel
NATURAL ESSENTIALS, INC.

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Drug Facts

Active ingredient

Menthol 4%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

Simple backache
Arthritis
Strains
Bruises
Sprains

Warnings

For external use only

Flammable:Keep away from fire or flame and heated surfaces

Do not use

if you are allergic to any ingredient in this product
on open wounds, damaged or irritated skin
with a heating pad or TENS device

When using this product

do not bandage tightly
do not use otherwise than as directed
avoid contact with eyes or mucous membranes
rare cases of burns have been reported with products of this type
if severe burning sensation occurs, discontinue use immediately

Stop use and ask a doctor if

condition worsens
rash, itching, redness or excessive irritation of the skin develops
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over:

apply to affected area using roller ball not more than 4 times daily
massage painful area until absorbed into skin
wash hands after each use with cold water

Children under 12 years of age:

consult a doctor

Other information

store in a cool place away from direct sunlight
store with cap closed tightly

Inactive ingredients

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana (Arnica Flower) Extract, Boswellia Serrata Extract, Calendula Officinalis (Calendula) Flower Extract, Camelia Sinensis (Green Tea) Extract, Camphor, Carbomer 940, FD&C Blue #1, FD&C Yellow #5, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Organic Ilex Paraguariensis Leaf Extract, Tocopheryl Acetate, Triethanolamine, Silicone Dioxide, Water.

Principal Display Panel – 74 mL Bottle Label

CVS
Health ®

Roll-On
Foot Pain
Relief

MENTHOL 4%

Temporarily relieves
painful, achy feet
Soothes
aggravated
nerves

2.5 FL OZ (74 mL)

Principal Display Panel – 74 mL Bottle Label

CVS HEALTH ROLL-ON FOOT PAIN RELIEF
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66902-919
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	36 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66902-919-03	74 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2020	10/09/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	03/12/2020	10/09/2024

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Name	Address	ID/FEI	Business Operations
Establishment
NATURAL ESSENTIALS, INC.		947484713	manufacture(66902-919)

Revised: 10/2024

Document Id: 2411c3da-f478-3ab4-e063-6394a90ab3e4

Set id: 344f731e-f71e-433f-974b-aa3b2ff7ff1a

Version: 3

Effective Time: 20241009

NATURAL ESSENTIALS, INC.