FAST FREEZE- menthol gel 
Natural Essentials Inc.

Disclaimer: 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.

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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:

Warnings

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

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

………………………………….

………………………………….

3 oz (89 mL)

Principal Display Panel – Bottle Label
FAST FREEZE 
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66902-016
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 35 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66902-016-05 1 g in 1 PACKET
2 NDC:66902-016-03 1 g in 1 BOTTLE
3 NDC:66902-016-04 1 g in 1 TUBE
4 NDC:66902-016-16 1 g in 1 BOTTLE, PUMP
5 NDC:66902-016-32 1 g in 1 BOTTLE, PUMP
6 NDC:66902-016-01 1 g in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/01/2013
Labeler - Natural Essentials Inc. (947484713)
Establishment
Name Address ID/FEI Business Operations
Natural Essentials Inc. 947484713 MANUFACTURE(66902-016)

Revised: 12/2012
Document Id: f78e1578-1fb0-4096-b299-64d661f911a9
Set id: a96e3e41-871c-4cf3-93b6-af2a6246ded8
Version: 1
Effective Time: 20121231
 
Natural Essentials Inc.