COOL N HEAT- cool n heat spray 
NeilMed Pharmaceuticals, Inc.

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Cool n Heat

ACTIVE INGREDIENT PURPOSE

Menthol 16% Topical analgesic

Uses

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

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.

Directions:

Shake well – adults and children 12 year 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.

Inactive ingredients:

Glycerin, propylene Glycol, SD Alcohol 40 (58%), USP grade purified Water.

Dosage and Administration

Shake well
adults and children 12 years of age and older spray on affected area not more than 3 to 4 times daily

children under 12 years of age consult a doctor

Indication & Usage

temporarily relief of pain and itching associated with

arthritis simple backache muscle strains bruises cramps muscle sprains

OTC - Keep Out of Reach of Children

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away

If pregnant or breast-feeding, ask a health professional before use.

OTC Purpose Section

temporarily relief of pain and itching associated with:

arthritis • simple backache • muscle strains • bruises • cramps • muscle sprains

Cool 'n heat, 16% Menthol/Pain relieving Spray

Cool and Heat

COOL N HEAT 
cool n heat spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-311
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL160 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13709-311-01118 mL in 1 CAN; Type 0: Not a Combination Product11/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/09/2018
Labeler - NeilMed Pharmaceuticals, Inc. (799295915)

Revised: 1/2024
Document Id: 0eb06bdb-c859-98c0-e063-6394a90ab3d6
Set id: a24cde17-280b-8358-e053-2a95a90af67d
Version: 6
Effective Time: 20240111
 
NeilMed Pharmaceuticals, Inc.