Fast freeze gel

Spl unclassified section

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:

  • 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:

  • Rub on the affected area not more than 3 to 4 times daily
  • Shake well before use

Spl unclassified section

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

Ingredients and appearance - Product information

Fast freeze gel- Camphor (natural), menthol

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 66902-000
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Camphor (natural) ( UNII: N20HL7Q941)( Camphor (natural) - UNII: N20HL7Q941 ) 2 mgin 1 g
Menthol ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) 35 mgin 1 g

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA

Labeler - Natural Essentials Inc.( 947484713)

Establishment

Name ID/FEI Business Operations
Natural Essentials Inc. 947484713 MANUFACTURE( 66902-000)

Package label.principal display panel

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)