DZUL FAST FREEZE INSTANT PAIN RELIEF- menthol spray

DZUL FAST FREEZE by

Drug Labeling and Warnings

DZUL FAST FREEZE by is a Otc medication manufactured, distributed, or labeled by Caball Sales, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 10.5%

PURPOSE

Topical Analgesic

USE

For temporary relief of minor aches and pains of muscles and joints.

WARNINGS

For external use only.

Do not apply to wounds or damaged skin, with a heating pad or on a child under 12 years of age.

Flammable

Keep away from fire or flame.

WHEN USING

Use only as directed.
Do not bandage tightly.
Avoid contact with eyes and mucous membranes.
If you experience an allergic reaction, discontinue use, and consult a doctor.

Do not expose the area treated with product to heat or direct sunlight.

Stop use and ask a doctor if

Condition worsens.
Redness is present.
Irritation develops.
Symptoms persist for more than 7 days or clear up occur again within a few days.

You experience signs of injury, such as pain, swelling or blistering where the product was applied.

PREGNANCY OR BREAST FEEDING

If pregnant or breast – feeding

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

Adults and Children over 12 years of age

Spray two to three pumps or as necessary to cover the affected area not more than three to four times daily.

Children under 12 years of age: do not use, consult a doctor.

OTHER INFORMATION

Store tightly closed in a dry place at controlled room temperature between 59-86 F (15°-30° C).

INACTIVE INGREDIENT

Alcohol Denat, Glycerin, Propylene Glycol, Aloe Barbadensis (Aloe Vera) Leaf Juice.

DZUL FAST FREEZE INSTANT PAIN RELIEF

INGREDIENTS AND APPEARANCE

DZUL FAST FREEZE  INSTANT PAIN RELIEF
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83037-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83037-105-04	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	06/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/30/2024

Labeler - Caball Sales, Inc. (047422138)