NDC | 0869-0005-34 |
Set ID | 3a5e5012-e77a-48a1-b4b1-706ab39ca178 |
Category | HUMAN OTC DRUG LABEL |
Packager | Vi-Jon, LLC |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- Active ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Do not use
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- principal display panel
-
INGREDIENTS AND APPEARANCE
SUNBURN RELIEF GEL
lidocaine hcl gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 5.05 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) TROLAMINE (UNII: 9O3K93S3TK) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZYL ALCOHOL (UNII: LKG8494WBH) MENTHOL (UNII: L7T10EIP3A) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0869-0005-34 226 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/10/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/10/2017 Labeler - Vi-Jon, LLC (790752542) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(0869-0005) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(0869-0005)