ICY FREEZE- menthol, unspecified form spray

ICY FREEZE by

Drug Labeling and Warnings

ICY FREEZE by is a Otc medication manufactured, distributed, or labeled by Natural Essentials, Inc., NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

NDC: 66902-168-40

Active ingredients

Menthol 10%

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains associated with:

• Tendonitis
• Strains
• Sprains
• Sore muscles
• Joint discomfort
• Arthritis

Warnings

• For external use only
• Flammable
• Keep away from excessive heat or open flame

Do not use

• With heating pad or device
• With creams, ointments, sprays or liniments
• On wounds damaged skin or irritated skin

Ask a doctor before use if you

• Have sensitive skin
• Are pregnant or breastfeeding

When using this product

• Avoid contact with eyes or mucous membranes
• Do not bandage tightly

Stop use and ask a doctor if

• Condition worsens
• Symptoms persist for more than 7 days or clear up then reoccur again within a few days
• Irritation develops

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

Directions

Adults/Children 2 years and older

• Apply to the affected area not more than 3 to 4 times daily; Rub into skin until solution vanishes

Children under 2 years old:

• Application should be supervised by an adult.

Other information

• Replace cap after use
• Store in a cool, dry place.

Inactive ingredients

Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis), dl-Camphor, SDA-39C Alcohol, dl-alpha Tocopheryl acetate, Purified Water.

Questions?

Call 317-689-7711

Principal Display Panel – 4 oz Can Label

THERAPEUTIC PAIN RELIEF

Greaseless and stain free with Aloe, Vitamin E and Ilex

NATURAL INGREDIENTS SOOTHING MENTHOL VANISHING SCENT

ICY FREEZE

COOLING PAIN RELIEF

FOR TENDONITIS, ARTHRITIS. SPRAINS AND STRAINS

FREEZES PAIN

360° CONTINUOUS SPRAY

4 FL OZ (120 mL)

INGREDIENTS AND APPEARANCE

ICY FREEZE 
menthol, unspecified form spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-168
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol, unspecified form (UNII: L7T10EIP3A) (Menthol, unspecified form - UNII:L7T10EIP3A)	Menthol, unspecified form	89 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-168-40	120 mL in 1 CAN; Type 0: Not a Combination Product	05/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/14/2020

Labeler - Natural Essentials, Inc. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(66902-168)