Label: BURN RELIEF EXTRA STRENGTH KOOL-DOWN- lidocaine - 3.9% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61566-117-04 - 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 January 16, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep Out of Reach of Children
- Uses
- Warnings
- Directions
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Inactive ingredients
Aloe Barbadensis Leaf Juice
Glycerin
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
Canola Oil
Fragrance - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BURN RELIEF EXTRA STRENGTH KOOL-DOWN
lidocaine - 3.9% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61566-117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 3.9 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) CANOLA OIL (UNII: 331KBJ17RK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61566-117-04 113 g in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 04/15/2013 Labeler - Kool-Down Inc (146580548) Registrant - CGI Packaging, LLC (080691099) Establishment Name Address ID/FEI Business Operations CGI Packaging, LLC 080691099 manufacture(61566-117)