Label: FAST FREEZE- menthol gel
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NDC Code(s):
66902-016-01,
66902-016-03,
66902-016-04,
66902-016-05, view more66902-016-16, 66902-016-32
- 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
If you are a consumer or patient please visit this version.
- 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
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
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66902-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 35 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:66902-016-05 1 g in 1 PACKET; Type 0: Not a Combination Product 01/01/2013 2 NDC:66902-016-03 1 g in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2013 3 NDC:66902-016-04 1 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2013 4 NDC:66902-016-16 1 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2013 5 NDC:66902-016-32 1 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/01/2013 6 NDC:66902-016-01 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(66902-016)