Your browser does not support JavaScript! FAST FREEZE (MENTHOL) SPRAY [NATURAL ESSENTIALS INC.]
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FAST FREEZE (menthol) spray
[Natural Essentials Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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)

Principal Display Panel – Bottle Label
FAST FREEZE 
menthol spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:66902-015
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL ALCOHOL 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66902-015-271 g in 1 BOTTLE, PUMP
2NDC:66902-015-041 g in 1 BOTTLE, PUMP
3NDC:66902-015-441 g in 1 CAN
4NDC:66902-015-161 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2013
Labeler - Natural Essentials Inc. (947484713)
Establishment
NameAddressID/FEIBusiness Operations
Natural Essentials Inc.947484713MANUFACTURE(66902-015)

Revised: 12/2012
 
Natural Essentials Inc.

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