NDC | 68848-001-01, 68848-001-02, 68848-001-03, 68848-001-04 |
Set ID | 1a99fa0e-a6c2-499f-81d4-79e2d052ff74 |
Category | HUMAN OTC DRUG LABEL |
Packager | Dermtech Labs Inc. dba GD Labs |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART346 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
- For Rectal use only
- For external use on intact skin only
- Do not use if pregnant or breast-feeding
- Do not exceed the recommended daily dosage unless directded by a doctor
- Avoid contact with eyes and mucous membranes
- You may experience temporary redness or stinging where the product is applied
- If irritation persists, consult your doctor
- Do not put product into the rectum by using fingers or any mechanical device or applicator
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TOPICAL ANESTHETIC ANORECTAL CREAM NUMB AND NUMBER
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68848-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 5 g in 100 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) BENZYL ALCOHOL (UNII: LKG8494WBH) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHOLESTEROL (UNII: 97C5T2UQ7J) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68848-001-02 1 in 1 PACKAGE 08/11/2016 1 NDC:68848-001-01 54 g in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:68848-001-04 1 in 1 PACKAGE 08/11/2016 2 NDC:68848-001-03 600 g in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 08/11/2016 Labeler - Dermtech Labs Inc. dba GD Labs (148077899) Registrant - Dermtech Labs Inc. dba GD Labs (148077899) Establishment Name Address ID/FEI Business Operations VEGE-KURL, INC 021072509 manufacture(68848-001)