Label: FAST FREEZE- menthol spray
- NDC Code(s): 66902-015-04, 66902-015-16, 66902-015-27, 66902-015-44
- Packager: Natural Essentials Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated November 15, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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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
- Directions
- Other information
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL
Principal Display Panel – Bottle Label
FAST FREEZE®
Naturally
CoolPain Relieving
Continuous 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)
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INGREDIENTS AND APPEARANCE
FAST FREEZE
menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66902-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 100 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F) ISOPROPYL ALCOHOL (UNII: ND2M416302) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66902-015-27 1 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2013 2 NDC:66902-015-04 1 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2013 3 NDC:66902-015-44 1 g in 1 CAN; Type 0: Not a Combination Product 01/01/2013 4 NDC:66902-015-16 1 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2013 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(66902-015)