NEILMED HOT AND COLD PAIN RELIEF- pain relief spray spray

NeilMed Hot and Cold Pain Relief by

Drug Labeling and Warnings

NeilMed Hot and Cold Pain Relief by is a Otc medication manufactured, distributed, or labeled by NeilMed Pharmaceuticals Inc., NeilMed Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directions

Directions: Shake well – adults and children 12 years of age and older: spray product on affected area, not more than 3 to 4 times daily. – children under 12 years of age: consult a doctor.

Warnings

For external use only.
Flammable: Do not use while smoking or near heat or flames. Avoid long term storage above 104°F. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.
When using this product avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not bandage tightly. Use only as directed.
Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use for longer than 1 week.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
If pregnant or breast-feeding, ask a health professional before use.

Inactive Ingredients

Glycerin, Propylene Glycol, SD Alcohol 40 (58%), USP grade Purified Water.

Uses

Temporarily alleviates minor aches and pains of muscles and joints associated with Arthritis, Simple Backache, Strains, Bruises, or Sprains

Warnings: Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Drug Facts:

Topical Analgesic

Drug Facts:

Active Ingredient

Menthol 16.0%

Package Label - NeilMed Hot & Cold Pain Relief

INGREDIENTS AND APPEARANCE

NEILMED HOT AND COLD PAIN RELIEF 
pain relief spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13709-238
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.16 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13709-238-01	118 g in 1 CAN; Type 0: Not a Combination Product	11/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/11/2020

Labeler - NeilMed Pharmaceuticals Inc. (799295915)

Establishment
Name	Address	ID/FEI	Business Operations
NeilMed Pharmaceuticals, Inc		799295915	manufacture(13709-238)