Fast Freeze (Camphor (Natural), Menthol) Spray [Natural Essentials Inc.] -

FAST FREEZE (CAMPHOR (NATURAL), MENTHOL) SPRAY [NATURAL ESSENTIALS INC.]
PDF | XML

NDC	66902-001-04, 66902-001-16, 66902-001-27, 66902-001-44
Set ID	ecafb26e-b813-45d3-ba6e-b416c30b73c2
Category	HUMAN OTC DRUG LABEL
Packager	Natural Essentials Inc.
Generic Name
Product Class
Product Number
Application Number	PART348

View All Sections

SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients

Camphor 0.2%, 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
- Contents under pressure. Do not puncture or incinerate container. Do not expose to temperature exceeding 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

Principal Display Panel – Can Label

EASY ONE-TOUCH SPRAY RELIEF

NEW!
BELL-HORN FAST
FREEZE® PAIN RELIEVING CONTINUOUS SPRAY

FREEZES PAIN
INSTANTLY!

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

4 oz (118 mL)

INGREDIENTS AND APPEARANCE

FAST FREEZE
camphor (natural), menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66902-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	2 mg in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:66902-001-27	1 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2010
2	NDC:66902-001-04	1 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2010
3	NDC:66902-001-44	1 g in 1 CAN; Type 0: Not a Combination Product	04/01/2010
4	NDC:66902-001-16	1 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/01/2010

Labeler - Natural Essentials Inc. (947484713)

Name	Address	ID/FEI	Business Operations
Establishment
Natural Essentials Inc.		947484713	MANUFACTURE(66902-001)

View All Sections

Medic

FAST FREEZE (CAMPHOR (NATURAL), MENTHOL) SPRAY [NATURAL ESSENTIALS INC.]

Do not use

Ask a doctor before use if you

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

Adults/Children 2 years and older:

Related Drugs