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Fast Freeze

Natural Essentials Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

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 (Aloe Vera) Leaf Extract, Carbomer, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methylparaben, Tocopherol (Vitamin E) Acetate, Triethanolamine, 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 Roll-On

Helps to relieve

  • Sore muscles
  • Strains & sprains
  • Joint pain

………………………………….

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

………………………………….

3 oz (89 mL)

Fast Freeze

Menthol GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:66902-016
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 35 mg

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
ILEX PARAGUARIENSIS LEAF
ISOPROPYL ALCOHOL
METHYLPARABEN
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66902-016-05 1 in 1 PACKET
2 NDC:66902-016-03 1 in 1 BOTTLE
3 NDC:66902-016-04 1 in 1 TUBE
4 NDC:66902-016-16 1 in 1 BOTTLE, PUMP
5 NDC:66902-016-32 1 in 1 BOTTLE, PUMP
6 NDC:66902-016-01 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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