Home NDC 0713-0623 Carlesta
Product NDC 0713-0623
11-digit product format 007130623
Labeler code 0713
Product ID 0713-0623_9b268d07-4090-4e8f-8604-3f9243b0ddfe
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone, Zinc Oxide
Dosage form OINTMENT
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 1999-09-08
Marketing end 0000-00-00
Substance DIMETHICONE; ZINC OXIDE
Active strength 20 mg/g; mg/g
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dimethicone ACTIVE INGREDIENT 92RU3N3Y1O CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Zinc Oxide ACTIVE INGREDIENT SOI2LOH54Z CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Dimethicone ACTIVE MOIETY 92RU3N3Y1O CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Zinc Oxide ACTIVE MOIETY SOI2LOH54Z CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Butylated Hydroxytoluene INACTIVE INGREDIENT 1P9D0Z171K CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Cod Liver Oil INACTIVE INGREDIENT BBL281NWFG CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Lanolin INACTIVE INGREDIENT 7EV65EAW6H CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Light Mineral Oil INACTIVE INGREDIENT N6K5787QVP CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Polysorbate 40 INACTIVE INGREDIENT STI11B5A2X CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Tea Tree Oil INACTIVE INGREDIENT VIF565UC2G CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R CARLESTA (DIMETHICONE, ZINC OXIDE) OINTMENT [G&W LABORATORIES, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0713-0623-04 00713062304 114 g in 1 TUBE (0713-0623-04) 114 g 1999-09-08 0000-00-00 No No Current 0713-0623-32 00713062332 56.8 g in 1 TUBE (0713-0623-32) 56.8 g 1999-09-08 0000-00-00 No No Current