Label: HUNTER BEACH 4%- lidocaine lotion
- NDC Code(s): 82517-001-04
- Packager: HUNTERS BEACH LIFE
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated April 11, 2022
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- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
Do not use in large quantities, particularly over raw surfaces or areas with blisters.
When using this product avoid contact with eyes. Use only as directed. Intentional misuse by deliberate concentrating and inhaling the contents can be harmful or fatal.
Stop use and consult a doctor if condition worsens, or symptoms last more than 7 days. Symptoms clear up and occur again within a few days. - Directions
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Inactive ingredients
Aloe Barbadensis Leaf Juice, Carthamus Tinctorius (Safflower) Seed Oil, Glycerin, Cetearyl Alcohol, Polysorbate 60, Microcrystalline Cellulose, Algin, Glyceryl Stearate, Sorbitan Caprylate, Propanediol, Benzoic Acid, Euphorbia Cerifera (Candelilla) Wax, Tocopheryl Acetate, Fragrance, Triethanolamine
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
HUNTER BEACH 4%
lidocaine lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82517-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) SAFFLOWER OIL (UNII: 65UEH262IS) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM ALGINATE (UNII: C269C4G2ZQ) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SORBITAN MONOCAPRYLATE (UNII: 1VTA8DCP5Q) PROPANEDIOL (UNII: 5965N8W85T) BENZOIC ACID (UNII: 8SKN0B0MIM) CANDELILLA WAX (UNII: WL0328HX19) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82517-001-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/01/2022 Labeler - HUNTERS BEACH LIFE (034619724) Establishment Name Address ID/FEI Business Operations Absolutely Natural 166425202 manufacture(82517-001)