Label: FAST FREEZE (camphor- natural, menthol spray
- NDC Code(s): 66902-001-04, 66902-001-16, 66902-001-27, 66902-001-44
- 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 October 18, 2018
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- 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
- 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
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAST FREEZE
camphor (natural), menthol sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66902-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 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:66902-001-27 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/01/2010 Labeler - Natural Essentials Inc. (947484713) Establishment Name Address ID/FEI Business Operations Natural Essentials Inc. 947484713 MANUFACTURE(66902-001)