NDC | 15127-002-16 |
Set ID | a74fd985-2b1d-4849-9a91-ee82f8dcab29 |
Category | HUMAN OTC DRUG LABEL |
Packager | Select Brand Distributors |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
When using this product
- avoid contact with eyes.
- do not use in large quantities, particularly over raw surfaces or blistered areas
- Directions
- Inactive ingredients
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
SELECT BRAND BURN RELIEF
lidocaine hcl gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15127-002-16 226 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/19/2012 Labeler - Select Brand Distributors (043562370)