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Fast Freeze

Natural Essentials Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

Menthol 10%

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
  • Avoid spraying in eyes
  • Contents under pressure. Do not puncture or incinerate container. Do not store at temperature above 120°F (48°C)

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:

  • Spray 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 (Aloe Vera) Leaf Extract, Ilex Paraguariensis Leaf Extract,SDA-39c Alcohol, Tocopherol (Vitamin E) Acetate, Water

Questions?

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

Principal Display Panel – Bottle Label

FAST FREEZE ®

Naturally
Cool

Pain Relieving

Continuouse Spray

Helps to relieve

  • Sore muscles
  • Strains & sprains
  • Joint pain

………………………………….

  • Invigorating cooling menthol
  • Greaseless & stain-free
  • Natural ingredients include
    Vitamin E, Aloe & llex

………………………………….

4 oz (118 mL)

Fast Freeze

MENTHOL SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:66902-015
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 100 mg

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
ILEX PARAGUARIENSIS LEAF
ISOPROPYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66902-015-27 1 in 1 BOTTLE, PUMP
2 NDC:66902-015-04 1 in 1 BOTTLE, PUMP
3 NDC:66902-015-44 1 in 1 CAN
4 NDC:66902-015-16 1 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-01-01


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Be sure to consult your doctor before taking any medication!
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