COLD AND HOT SCHERER LABS- menthol 7.6% mehyl salicylate 29.0% spray

Cold and Hot by

Drug Labeling and Warnings

Cold and Hot by is a Otc medication manufactured, distributed, or labeled by Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Menthol 7.60%
Methyl Salicylate 29.00%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and
joints associated with: arthritis simple backache muscle strains
bruises sprains

Warnings

For external use only.

Flammable keep away from fire or flame do not use while smoking or
near heat or flame 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 symptoms persist for
more than 7 days or clear up and occur again within a few days needed for
longer than 1 week
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get help or contact a Poison Control Center right away.

Directions

shake well adults and children 2 years of age and older:
spray product on affected area, not more than 3 to 4 times
daily. children under 2 years of age: consult a doctor

Inactive ingredients

Alcohol Denat.
Arnica Montana Flower Extract
Boswellia Serrata Gum Extract
Dimethyl Sulfone
Eucalyptus Globulus Leaf Oil
Ilex Paraguariensis Leaf Extract
Mentha Piperita (Peppermint) Oil
Olea Europaea (Olive) Fruit Oil
Propylene Glycol
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COLD AND HOT  SCHERER LABS
menthol 7.6% mehyl salicylate 29.0% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64048-3334
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7.6 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	29.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
EUCALYPTUS OIL (UNII: 2R04ONI662)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
OLIVE OIL (UNII: 6UYK2W1W1E)
Propylene Glycol (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64048-3334-4	113 g in 1 CAN; Type 0: Not a Combination Product	11/13/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/13/2014

Labeler - Product Quest Mfg, LLC (927768135)

Registrant - Product Quest Mfg, LLC (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(64048-3334)