ICY FREEZE by NATURAL ESSENTIALS, INC. ICY FREEZE- menthol gel

ICY FREEZE by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

ICY FREEZE COOLING PAIN RELIEF

Drug Facts

Active ingredient

Menthol 3.5%

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.

Non-medicinal ingredients Aloe Barbadensis Leaf Extract, Mate (Ilex Paraguariensis) Extract, dl-alpha Tocopheryl acetate, Purified Water, dl-Camphor, Carbomer, Isopropyl alcohol, Methylparaben, Triethanolamine.

MADE IN USA for Healer Health LLC

Zionsville, Indiana 46077 TM Reg'd 85140-L

ICYFREEZE.COM

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Icy Freeze 3oz Gel Pump

FREEZES PAIN

THERAPUTIC 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

GEL

4 FL OZ (120 mL)

PRINCIPAL DISPLAY PANEL

Principal Display Panel - Icy Freeze 3oz Roll On

FREEZES PAIN

THERAPUTIC 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

ROLL-ON

3 FL OZ (90 mL)

INGREDIENTS AND APPEARANCE

ICY FREEZE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-165
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-165-03	1 in 1 BOTTLE, WITH APPLICATOR	12/01/2017
1		90 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 66902-165-04	1 in 1 BOTTLE, PUMP	12/01/2017
2		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/01/2017

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(66902-165)