IRELIEV ROLL ON COOL PAIN RELIEF- menthol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Excel Health, Inc
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises, and strains.
Authorization status:
OTC monograph not final
Authorization number:
72909-014-01

IRELIEV ROLL ON COOL PAIN RELIEF- menthol gel

Excel Health, Inc

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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iRELIEV Roll-On Cool Pain Relief Gel

Drug Facts

Active ingredient

Menthol 6%

Topical Analgesic

Indications :

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

simple backache, sprains, bruises, and strains.

Warnings

For external use only

Avoid contact with eyes

If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children

If swallowed, consult physician

Do not apply

to wounds or damaged skin

Do not bandage tightly

If pregnant or breast feeding

contact physician prior to use

Directions

Adults and children two-years of age or older: Apply to affected area not more than three to four

times dail

Children under two-years of age: consult a physician

Other information

store at room temperature

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arctium Lappa (Burdock)

Root Extract, Arnica Montana Extract, Boswellia Serrata Extract, Calendula Officinalis Extract,

Camellia Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis

(Yerba Mate’) Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm)

Extract, Phenoxyethanol, Polysorbate- 20, Tocopheryl Acetate (Vitamin E), Triethanolamine

Package Labeling:

IRELIEV ROLL ON COOL PAIN RELIEF

menthol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:729 0 9 -0 14

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

6 0 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Excel Health, Inc

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

WATER (UNII: 0 59 QF0 KO0 R)

ARCTIUM LAPPA RO O T (UNII: 59 7E9 BI3Z3)

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW)

CALENDULA O FFICINALIS FLO WER (UNII: P0 M7O4Y7YD)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

GLYCERIN (UNII: PDC6 A3C0 OX)

ILEX PARAGUARIENSIS LEAF (UNII: 1Q9 53B4O4F)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

MELISSA O FFICINALIS (UNII: YF70 18 9 L0 N)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

.ALPHA.-TO CO PHERO L ACETATE, D- (UNII: A7E6 112E4N)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:729 0 9 -0 14-0 1

8 8 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/20 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 2/20 /20 19

Labeler -

Excel Health, Inc (079213529)

Revised: 5/2019

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