POINT RELIEF COLD SPOT PAIN RELIEVING- menthol gel

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

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Fabrication Enterprises
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains, and/ or sprains.
Authorization status:
OTC monograph not final
Authorization number:
51452-035-01, 51452-035-02, 51452-035-03, 51452-035-04, 51452-035-05

POINT RELIEF COLD SPOT PAIN RELIEVING- menthol gel

Fabrication Enterprises

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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Point Relief Cold Spot Pain Relieving Gel

Drug Facts

Active Ingredients:

menthol - USP 12%

Purpose:

external analgesic

Uses:

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

backache, arthritis, bruises, strains, and/ or sprains.

Warnings:

For external use only

Avoid contact with eyes

Do not apply

to open wounds or damaged skin

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

Keep out of reach of children

If swallowed, consult physician

Do not bandage tightly

Directions:

Apply directly to affected area. Do not use more than four fimes per day.

Other Ingredients:

aqua (deionized water), arnica montana flower (arnica) extract, boswellia serrata extract, bromelain,

carbomer, diazolidinyl urea, eucalyptus globulus oil, glycyrrhiza glabra (licorice) extract, ilex

paraguariensis leaf (yerba mate) extract, mentha piperita (peppermint) oil, methyl salicylate, MSM

(dimethyl sulfone), polysorbate-80, propyl paraben, propylene glycol, SD-alcohol 40B, triethanolamine

Point Relief Cold Spot Pain Relieving Gel, 120mL (51452-035-01)

Point Relief cold Spot Pain Relieving Gel, 475mL (51452-035-02)

Point Relief cold Spot Pain Relieving Gel, 3.8L (51452-035-03)

Point Relief cold Spot Pain Relieving Gel, 420mL(Hands Free)(51452-035-04)

Point Relief cold Spot Pain Relieving Gel, 950mL (51452-035-05)

POINT RELIEF COLD SPOT PAIN RELIEVING

menthol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51452-0 35

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

120 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ)

Fabrication Enterprises

INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)

BRO MELAINS (UNII: U18 2GP2CF3)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)

GLYCYRRHIZA GLABRA (UNII: 278 8 Z9 758 H)

ILEX PARAGUARIENSIS LEAF (UNII: 1Q9 53B4O4F)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

METHYL SALICYLATE (UNII: LAV5U50 22Y)

DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:51452-0 35-0 1

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

0 4/0 1/20 19

2

NDC:51452-0 35-0 2

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

0 4/0 1/20 19

3

NDC:51452-0 35-0 3

38 0 0 mL in 1 JUG; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 1/20 19

4

NDC:51452-0 35-0 4

420 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 1/20 19

5

NDC:51452-0 35-0 5

9 50 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 1/20 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 4/0 1/20 19

Labeler -

Fabrication Enterprises (070577218)

Revised: 4/2019

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