FAST FREEZE- camphor (natural), 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.

----------

Drug Facts

Active ingredients

Camphor 0.2%, 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:

  • Rub 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, Pump Label

NEW!
BELL-HORN
FAST FREEZE®
PAIN RELIEVING GEL

FREEZES PAIN
INSTANTLY!

HELPS TO RELIEVE:
- SORE MUSCLES
- STRAINS & SPRAINS
- JOINT PAIN
(GREAT FOR ARTHRISTIS)

16 oz (473 mL)

Principal Display Panel – Bottle, Pump Label
FAST FREEZE 
camphor (natural), menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)2 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL35 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66902-000-051 g in 1 PACKET; Type 0: Not a Combination Product04/01/2010
2NDC:66902-000-031 g in 1 BOTTLE; Type 0: Not a Combination Product04/01/2010
3NDC:66902-000-041 g in 1 TUBE; Type 0: Not a Combination Product04/01/2010
4NDC:66902-000-161 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2010
5NDC:66902-000-321 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2010
6NDC:66902-000-011 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/01/2010
Labeler - Natural Essentials Inc. (947484713)
Establishment
NameAddressID/FEIBusiness Operations
Natural Essentials Inc.947484713MANUFACTURE(66902-000)

Revised: 10/2018
Document Id: 155ae528-75a1-40fb-9daf-c8956c37c6f6
Set id: 60c94da8-6c00-4544-a9a6-a3e87ebabd68
Version: 3
Effective Time: 20181018
 
Natural Essentials Inc.