NDC | 76348-415-01 |
Set ID | 433d5e6b-f608-0d93-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Renu Laboratories, Inc. |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART346 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
-
WHEN USING
When using this product
- Use only as directed. Read and follow all directions and warnings on this label.
- rare cases of serious burns have been reported with products of this type
- do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated patch
- avoid contact with eyes and mucous membranes
- a transient burning sensation may occur upon application but generally disappears in several days
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INSTRUCTIONS FOR USE
- INACTIVE INGREDIENT
- QUESTIONS
- STATEMENT OF IDENTITY
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TLC PLUS ANESTHETIC S
lidocaine sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76348-415 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2.36 g in 59 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ALCOHOL (UNII: 3K9958V90M) BENZYL ALCOHOL (UNII: LKG8494WBH) ALOE (UNII: V5VD430YW9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76348-415-01 59 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/28/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 07/28/2017 Labeler - Renu Laboratories, Inc. (945739449) Establishment Name Address ID/FEI Business Operations Renu Laboratories, Inc. 945739449 manufacture(76348-415)