FAST FREEZE PAIN RELIEVING- menthol, unspecified form gel

Fast Freeze Pain Relieving by

Drug Labeling and Warnings

Fast Freeze Pain Relieving by is a Otc medication manufactured, distributed, or labeled by NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Menthol 3.5%

Purpose

Cooling Pain Relief

Uses

Temporary relief of minor aches and pains of muscles and joints associated with:

• Simple backache
• Arthritis
• Strains
• Sprains

Warnings

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

Do not use

• With heating pad or device
• With ointments, creams, 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:

• Roll on the affected area not more than 3 to 4 times daily
• Shake well before use

Children under 2 years old:Consult a physician.

Other information

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

Inactive ingredients

Aloe Barbadensis Leaf Extract, Carbomer, dl-alpha Tocopheryl Acetate, dl-Camphor, Isopropyl Alcohol, Mate (Ilex Paraguariensis) Extract, Methylparaben, Triethanolamine, Water.

Questions?

Call 317-228-1144 or visit www.Bell-Horn.com or www.fastfreeze.com

Principal Display Panel - 89 mL Container Label

FAST FREEZE®

Naturally
Cool
Pain Relieving Roll-On

Helps to relieve

• Sore muscles
• Strains & sprains
• Joint pain
• Invigorating, cooling menthol
• Greaseless & stain-free
• Natural ingredients include
  Vitamin E, Aloe & Ilex

3 oz (89 mL)

Principal Display Panel - 120 mL Tube Label

FAST FREEZE®

Naturally
Cool
Pain Relieving Gel

Helps to relieve

• Sore muscles
• Strains & sprains
• Joint pain
• Invigorating, cooling menthol
• Greaseless & stain-free
• Natural ingredients include
  Vitamin E, Aloe & Ilex

Net wt. 4 oz (113 g)

INGREDIENTS AND APPEARANCE

FAST FREEZE PAIN RELIEVING 
menthol, unspecified form gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-116
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	33 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-116-03	89 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/31/2021
2	NDC: 66902-116-04	120 mL in 1 TUBE; Type 0: Not a Combination Product	10/06/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/31/2021

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	manufacture(66902-116)