POINT RELIEF COLD SPOT PAIN RELIEVING- menthol spray

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:
51452-038-01, 51452-038-02

POINT RELIEF COLD SPOT PAIN RELIEVING- menthol spray

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 spray

Drug Facts

Active Ingredients:

menthol - USP 10%

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, chondroitin sulfate, citric acid,

eucalyptus globulus oil, glucosamine sulfate, ilex paraguariensis leaf (yerba mate) extract, isopropyl

alcohol, mentha piperita (peppermint) oil, MSM (dimethyl sulfone), polysorbate-20, SD-alcohol 40B

Point Relief cold Spot Pain Relieving spray, 120mL (51452-038-01)

Point Relief cold Spot Pain Relieving Spray, 475mL (51452-038-02)

POINT RELIEF COLD SPOT PAIN RELIEVING

menthol spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:51452-0 38

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

10 0 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)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

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

GLUCO SAMINE SULFATE (UNII: 1FW7WLR731)

ILEX PARAGUARIENSIS LEAF (UNII: 1Q9 53B4O4F)

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

Fabrication Enterprises

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT)

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

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:51452-0 38 -

120 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/0 1/20 19

2

NDC:51452-0 38 -

475 mL in 1 BOTTLE, SPRAY; Type 0 : No t a Co mbinatio n

Pro duc t

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)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pure So urce, LLC

0 8 0 354456

ma nufa c ture (51452-0 38 )

Revised: 4/2019

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