PAIN RELIEF- analgesic menthol spray

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

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Active ingredient:
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Unifirst First Aid Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical analgesic Temporary relief of minor aches and pains of muscles and joints.
Authorization status:
OTC monograph not final
Authorization number:
47682-321-02

PAIN RELIEF- analgesic menthol spray

Unifirst First Aid Corporation

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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Pain Relief Spray Green Guard

Drug Facts

Active ingredients

USP Menthol 7%

Purpose

Topical analgesic

Uses

Temporary relief of minor aches and pains of muscles and joints.

Warnings

For external use only. Flammable. Keep away from flame.

Do not use

on open wounds or damaged skin

Ask a doctor before use if

you are prone to allergic reactions to salicylates, including aspirin

When using this product

avoid contact with eyes

Stop use and ask a doctor if

condition worsens

symptoms persist for more than 7 days or clear up and recur again within a few days

excessive skin irritation occurs

If pregnant or breast feeding,

ask a doctor 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 (2 years and older):

Shake well and aply to affected araea not more than 3-4 times daily.

Do not bandage tightly.

Children under 2 years:

Consult a doctor

Other information

store at room temperature 56°-86°F (15°-30°C)

will not stain clothing

Inactive ingredients

coconut oil, eucalyptus lkeaf oil, glycerol, isopropyl alcohol, peppermint oil, water, wintergreen leaf

Questions or comments?

1-800-869-6970

Green Guard Pain Relief Spray Label

Pain Relief spray

Fast Acting pain Relief

For Temporary Relief of Minor Aches and Pains

Green Guard®

2 Fl. Oz. (59.1 mL)

PAIN RELIEF

analgesic menthol spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:476 8 2-321

Unifirst First Aid Corporation

Product T ype

Ite m Code (Source )

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

70 mg in 1 L

Inactive Ingredients

Ingredient Name

Stre ng th

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

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

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

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

METHYL SALICYLATE (UNII: LAV5U50 22Y)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:476 8 2-321-

0 .0 59 L 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 -

Unifirst First Aid Corporation (832947092)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Prestige Packaging

170 8 379 6 2

relabel(476 8 2-321) , repack(476 8 2-321)

Revised: 6/2020

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