Indications and uses
helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness
COZIMA
- Manufacturer
- GM Pharmaceuticals, INC
- Effective date
- 2022-01-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:17:29
Label at a glance#
ProductCOZIMA
Active ingredientZINC OXIDE
Label structure10 sections
Dosage and administration
For diaper rash : change wet and soiled diapers promptly cleanse the diaper area and allow to dry apply cream liberally, as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
COZIMA DIAPER RASH CREAM
Zinc Oxide Skin Protectant
Net wt. 4oz (113g)
NDC 58809-450-04
Drug Facts
Active Ingredient
Zinc Oxide 24%
Purpose
Skin Protectant
Uses
- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash and helps seal out wetness
Warnings
For external use only
When using this product
avoid contact with eyes
Stop use and ask a doctor if
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
For diaper rash:
- change wet and soiled diapers promptly
- cleanse the diaper area and allow to dry
- apply cream liberally, as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Other Information
- Lot No. and Exp. Date: see crimp of tube
- Store at room temperature 20° - 25° C (59°- 86° F)
Inactive Ingredients
acrylates/acrylamide copolymer, ceteareth-25, citronella oil, coconut oil, dimethicone, disodium EDTA, glycerin, isopropyl myristate, lemongrass oil, mineral oil, octyldodecanol, peg-20 methyl glucose sesquistearate, polysorbate 85, propylene glycol stearate , purified water, stearyl alcohol, tea tree oil
Questions?
Call 1-888-535-0305 Mon-Fri 9AM – 5PM
PRINCIPAL DISPLAY PANEL
NDC 58809-450-04
COZIMA
DIAPER RASH CREAM
Zinc Oxide
Skin Protectant
NET Wt 4 OZ (113 g)
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58809-450-04 | GM - Gram | 58809-450 | 6eec96e9-1281-4b92-a4be-07cc769ad587 | 1 | 2018-12-13 |
Products#
Every source-derived product name is available through these pages.
- COZIMA
- Zinc Oxide
- CETEARETH-25
- PROPYLENE GLYCOL STEARATE
- CITRONELLA OIL
- COCONUT OIL
- DIMETHICONE
- EDETATE DISODIUM
- GLYCERIN
- ISOPROPYL MYRISTATE
- WEST INDIAN LEMONGRASS OIL
- MINERAL OIL
- OCTYLDODECANOL
- PEG-20 METHYL GLUCOSE SESQUISTEARATE
- POLYSORBATE 85
- WATER
- STEARYL ALCOHOL
- TEA TREE OIL
- ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58809-450 | 58809-450-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 0b27f6d0-e0ce-63a2-e063-6294a90a451f | ac1faa46-2e2a-4500-9d32-e51da7b2fe43 | 2023-11-27 | Warnings | ac1faa46-2e2a-4500-9d32-e51da7b2fe43 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.