Label: BURN RELIEF PROFESSIONAL BIO-KOOL- lidocaine - 4% cream
- NDC Code(s): 61566-201-04
- Packager: Kool-Down 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 February 22, 2019
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- ACTIVE INGREDIENT
- PURPOSE
- Uses
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Aloe Barbadensis Leaf Juice, Glycerol, Stearic Acid, Glyceryl Stearate SE, Isopropyl Myristate, Ethoxydiglycol, Ozokerite, Polysorbate 80, Carbomer, Zinc Oxide, Allantoin, Ascorbic Acid, Methylparaben, Diazolidinyl Urea, Propylparaben, Triethanolamine, Tetrasodium EDTA, Tocopheryl Acetate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Fragrance.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BURN RELIEF PROFESSIONAL BIO-KOOL
lidocaine - 4% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61566-201 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 g Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) GLYCERIN (UNII: PDC6A3C0OX) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) CERESIN (UNII: Q1LS2UJO3A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) ZINC OXIDE (UNII: SOI2LOH54Z) ALLANTOIN (UNII: 344S277G0Z) ASCORBIC ACID (UNII: PQ6CK8PD0R) METHYLPARABEN (UNII: A2I8C7HI9T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) PROPYLPARABEN (UNII: Z8IX2SC1OH) TROLAMINE (UNII: 9O3K93S3TK) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALMOND OIL (UNII: 66YXD4DKO9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61566-201-04 113 g in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/15/2013 Labeler - Kool-Down Inc. (146580548) Registrant - Derma Care Research Labs (116817470) Establishment Name Address ID/FEI Business Operations Derrma Care Research Labs 116817470 manufacture(61566-201)