HOT STUFF- menthol, methyl salicylate cream

Hot Stuff by

Drug Labeling and Warnings

Hot Stuff by is a Otc medication manufactured, distributed, or labeled by Mueller Sports Medicine. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients

Menthol 3%

Methyl Salicylate 15%

Pupose

Purpose

Topical Analgesic

Topical Analgesic

Uses

Temporarily relieves pain from

• sore muscles
• minor aches
• sprains
• strains
• bruises

WARNINGS

For external use only

Allergy alert: If prone to allergic reaction from menthol, aspirin or salicylates, consult a doctor before use.

When using this product

• use only as directed
• avoid contact with eyes or mucous membranes
• do not apply to wounds or damaged skin
• do not bandage tightly
• do not use with a heating pad
• do not use immediately after a shower or bath

Stop use and ask a doctor

Stop use and ask a doctor if condition worsens

• symptoms persist for more than 7 days or clear up and occur again within a few days
• skin redness is present
• excessive skin irritation occurs

If pregnant or breast-feeding

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

Keep out of reach of children

Keep out of children

• if swallowed, get medical help or contact a Poison Control center right away

Directions

Adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: ask a doctor

Inactive ingredients

Cetyl Alcohol, Cetyl Palmitate, Glyceryl Stearate, Methyl Paraben, Mineral Oil, Polysorbate 80, Propylene Glycol, Propyl Paraben, Water

Questions or comments?

Call 1-800-356-9522 or

Email us at sportcare@muellersportsmed.com

OTHER SAFETY INFORMATION

STORE AT NORMAL ROOM TEMPERATURE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOT STUFF 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52564-108
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.03 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.15 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52564-108-01	237 g in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2019

Labeler - Mueller Sports Medicine (006426316)