Label: FAST FREEZE LIDOCAINE- lidocaine spray
- NDC Code(s): 66902-225-04
- Packager: Natural Essentials, Inc.
- Category: HUMAN OTC DRUG LABEL
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 July 10, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
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WARNINGS
For external use only
WHEN USING THIS PRODUCT
- Keep out of eyes
- Use only as directed
- do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F
- DIRECTIONS
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INACTIVE INGREDIENTS
Acrylates/C10-30 Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Deionized Water, Diazolidinyl Urea. Dimethicone, Disodium Cocamphodipropionate. Disodium EDTA, Glycerin. Propylene Glycol, SDA 39C Alcohol, Tocopheryl Acetate, Triethanolamine.
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Principal Display Panel – 118 mL Can Label
FAST FREEZE®
MAXIMUM STRENGTH
LIDOCAINE
CONTINUOUS SPRAYUNSCENTED
- Numbing relief
- No mess, greaseless & stain-free
- Natural ingredients include
Vitamin E and Aloe - For the temporary relief of
minor aches and pains of muscles
and joints; associated with backache,
arthritis, strains and sprains - Paraben Free
- Fast Drying
3 oz (89 mL)
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INGREDIENTS AND APPEARANCE
FAST FREEZE LIDOCAINE
lidocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66902-225 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ALOE VERA LEAF (UNII: ZY81Z83H0X) MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02) CUCUMBER (UNII: YY7C30VXJT) WATER (UNII: 059QF0KO0R) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIMETHICONE (UNII: 92RU3N3Y1O) DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66902-225-04 118 mL in 1 CAN; Type 0: Not a Combination Product 07/10/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/10/2020 Labeler - Natural Essentials, Inc. (947484713) Establishment Name Address ID/FEI Business Operations NATURAL ESSENTIALS, INC. 947484713 MANUFACTURE(66902-225)