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NDC 47682-0235-02 Medi-First Pain Relief 70 mg/L Details

Medi-First Pain Relief 70 mg/L

Medi-First Pain Relief is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Unifirst First Aid Corporation. The primary component is MENTHOL.

Product Information

NDC	47682-0235
Product ID	47682-235_ebdc9f77-852f-46e7-e053-2995a90a4303
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Medi-First Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	Analgesic- menthol
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	mg/L
Substance Name	MENTHOL
Labeler Name	Unifirst First Aid Corporation
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 47682-0235-02 (47682023502)

Pricing Information	N/A
NDC Package Code	47682-235-02
Billing NDC	47682023502
Package	.059 L in 1 BOTTLE, SPRAY (47682-235-02)
Marketing Start Date	2019-04-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8154a8f2-290c-06e3-e053-2a91aa0a5f41 Details

Drug Facts

Active ingredient

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

Asl a doctor before use if

you are prone to allergic reactions to salicylates, including aspirin

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

condition worsens
symptoms persist for more than 7 days or clear upand 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, grt medical help or contact a Poison Control Center right away.

Directions

Adults and children (2 years and older):

Shake well and apply to affected area not more than 3-4 times daily.

Do not bandage tightly.

Children under 2 years:

consult a doctor.

Other information

store at room temperature 59°- 86°F (15°- 30”C)
will not stain clothing

Inactive ingredients

coconut oil, eucalyptus leaf oil, glycerol, isopropyl alcohol, peppermin oil, water, wintergreen leaf oil

Questions or comments?

1-800-634-7680

Medi-First Pain Relief Spray Label

Medi-First®

Pain Relief Spray

Pump Spray

Medicated • Fast Acting

• For the temporary relief of minor aches and pains

2 FL OZ (59.1 mL)

INGREDIENTS AND APPEARANCE

MEDI-FIRST PAIN RELIEF

analgesic- menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47682-235
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	70 mg in 1 L

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL ALCOHOL (UNII: ND2M416302)
EUCALYPTUS OIL (UNII: 2R04ONI662)
METHYL SALICYLATE (UNII: LAV5U5022Y)
COCONUT OIL (UNII: Q9L0O73W7L)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47682-235-02	0.059 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/01/2019

Labeler - Unifirst First Aid Corporation (832947092)

Revised: 10/2022

Document Id: ebdc9f77-852f-46e7-e053-2995a90a4303

Set id: 8154a8f2-290c-06e3-e053-2a91aa0a5f41

Version: 5

Effective Time: 20221025