NDC 53462-915 – Comfort Shield Barrier
Dimethicone 30 mg/g · Cloth · Topical
Product NDC53462-915
Product details
- Brand name
- Comfort Shield Barrier
- Generic name
- Dimethicone
- Labeler
- Sage Products LLC
- Dosage form
- Cloth
- Route
- Topical
- Marketing category
- OTC MONOGRAPH DRUG · M016
- Marketed since
- January 1, 1990
- Listing expires
- December 31, 2027
Active ingredients
- Dimethicone 30 mg/g
Uses, dosage, side effects and warnings for Comfort Shield Barrier →
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 53462-915-24 | 24 APPLICATOR in 1 PACKAGE (53462-915-24) / 24 g in 1 APPLICATOR | Dec 11, 2023 |
| 53462-915-50 | 3 APPLICATOR in 1 PACKAGE (53462-915-50) / 26 g in 1 APPLICATOR | Jan 1, 1990 |
| 53462-915-51 | 3 APPLICATOR in 1 PACKAGE (53462-915-51) / 19 g in 1 APPLICATOR | Jan 1, 1990 |
| 53462-915-80 | 8 APPLICATOR in 1 PACKAGE (53462-915-80) / 27 g in 1 APPLICATOR | Jan 1, 1990 |
Recalls mentioning this NDC
- D-0229-2017 Dec 28, 2016 · Class I
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia. - D-0230-2017 Dec 28, 2016 · Class II
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product. - D-1573-2014 Sep 10, 2014 · Class II
Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination.