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| NDC | 69804-036-02, 69804-036-03, 69804-036-05, 69804-036-06 |
| Set ID | 47f59fa0-026d-6116-e054-00144ff88e88 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | ridge properties |
| Generic Name | |
| Product Class | Amide Local Anesthetic, Antiarrhythmic |
| Product Number | |
| Application Number | PART348 |
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EXTRA STRENGTH NATURALLY HL WARMING ICE
lidocaine hcl creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69804-036 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 40 mg in 1000 mg Inactive Ingredients Ingredient Name Strength BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61) 50 mg in 1000 mg BLACK PEPPER OIL (UNII: U17J84S19Z) 40 mg in 1000 mg GRAPE SEED OIL (UNII: 930MLC8XGG) 120 mg in 1000 mg EUCALYPTUS OIL (UNII: 2R04ONI662) 40 mg in 1000 mg OLIVE OIL (UNII: 6UYK2W1W1E) 120 mg in 1000 mg WHITE WAX (UNII: 7G1J5DA97F) 40 mg in 1000 mg COCOA BUTTER (UNII: 512OYT1CRR) 25 mg in 1000 mg ALOE VERA WHOLE (UNII: KIZ4X2EHYX) 525 mg in 1000 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69804-036-06 14200 mg in 1 JAR; Type 0: Not a Combination Product 02/09/2017 2 NDC:69804-036-05 28500 mg in 1 JAR; Type 0: Not a Combination Product 02/09/2017 3 NDC:69804-036-02 56700 mg in 1 JAR; Type 0: Not a Combination Product 02/09/2017 4 NDC:69804-036-03 113400 mg in 1 JAR; Type 0: Not a Combination Product 02/09/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/09/2017 Labeler - ridge properties (029478762) Establishment Name Address ID/FEI Business Operations ridge properties 029478762 manufacture(69804-036)
