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![BURNZONE (PAIN RELIEVING CREAM) CREAM [MEDZONE PRODUCTS LLC]](https://medic.hrt.org//dailymed/images/37898703-be54-2853-e054-00144ff88e88/foil burn front.jpg)
| NDC | 70338-621-12 |
| Set ID | 37898703-be54-2853-e054-00144ff88e88 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | MedZone Products LLC |
| Generic Name | |
| Product Class | Amide Local Anesthetic, Antiarrhythmic |
| Product Number | |
| Application Number | PART348 |
- Active Ingredient
- Purpose
- Uses
-
Warnings
For external use only
Stop use and ask a physician if
- Allergic reaction occirs
- condition worsens or does not improve within 7 days
- symptoms clear up and return withina few days
- redness, irritation, swelling, pain or other symptoms begin or increase
- Directions
- Other Information
-
Inactive Ingredients
Allantoin, Aloe Vera Leaf, Alpha-Tocopheryl Acetate, Carboxypolymethylene, Chamaemelum Nobile Flower, Cetostearyl Alchol, Cetyl Alcohol, Clove Oil, Duazolidinyl Urea, Glycerin, Green Tea Leaf, Hyaluronate Sodium, Hydrogenated Soybean Lecithin, Iodopropynyl Butylcarbamate, Medium-Chain Triglycerides, Oleic Acid, Panthenol, Peppermint Oil, Polyoxyl 20 Cetostearyl Ether, Tea Tree Oil, Trolamine, Water
- Questions?
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BURNZONE
pain relieving cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70338-621 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER 934 (UNII: Z135WT9208) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) OLEIC ACID (UNII: 2UMI9U37CP) PANTHENOL (UNII: WV9CM0O67Z) TEA TREE OIL (UNII: VIF565UC2G) CLOVE OIL (UNII: 578389D6D0) GLYCERIN (UNII: PDC6A3C0OX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PEPPERMINT OIL (UNII: AV092KU4JH) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALLANTOIN (UNII: 344S277G0Z) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70338-621-12 3.6 g in 1 POUCH; Type 0: Not a Combination Product 07/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 07/01/2016 Labeler - MedZone Products LLC (080083739) Registrant - Richard Hamer Associates LLC (067731889) Establishment Name Address ID/FEI Business Operations Biomed Laboratories LLC 055329696 manufacture(70338-621) , pack(70338-621) Establishment Name Address ID/FEI Business Operations Microconsult Inc. 062183608 analysis(70338-621) Establishment Name Address ID/FEI Business Operations Ceutical Laboratories Inc. 789485153 analysis(70338-621)
