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NDC 58809-0450-04 COZIMA 24 g/100g Details

COZIMA 24 g/100g

COZIMA is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by GM Pharmaceuticals, INC. The primary component is ZINC OXIDE.

Product Information

NDC	58809-0450
Product ID	58809-450_d57d169f-3435-82eb-e053-2995a90a81bf
Associated GPIs	90971020003725
GCN Sequence Number	080205
GCN Sequence Number Description	zinc oxide CREAM (G) 24 % TOPICAL
HIC3	L3A
HIC3 Description	PROTECTIVES
GCN	46916
HICL Sequence Number	002361
HICL Sequence Number Description	ZINC OXIDE
Brand/Generic	Brand
Proprietary Name	COZIMA
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	24
Active Ingredient Units	g/100g
Substance Name	ZINC OXIDE
Labeler Name	GM Pharmaceuticals, INC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2023-12-31

Package

Package Images

NDC 58809-0450-04 (58809045004)

Pricing Information	N/A
NDC Package Code	58809-450-04
Billing NDC	58809045004
Package	113 g in 1 BOTTLE (58809-450-04)
Marketing Start Date	2018-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ac1faa46-2e2a-4500-9d32-e51da7b2fe43 Details

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)

INGREDIENTS AND APPEARANCE

COZIMA

zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58809-450
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CETEARETH-25 (UNII: 8FA93U5T67)
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)
CITRONELLA OIL (UNII: QYO8Q067D0)
COCONUT OIL (UNII: Q9L0O73W7L)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
MINERAL OIL (UNII: T5L8T28FGP)
OCTYLDODECANOL (UNII: 461N1O614Y)
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)
POLYSORBATE 85 (UNII: A7F3N56197)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TEA TREE OIL (UNII: VIF565UC2G)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58809-450-04	113 g in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	10/01/2018

Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 1/2022

Document Id: d57d169f-3435-82eb-e053-2995a90a81bf

Set id: ac1faa46-2e2a-4500-9d32-e51da7b2fe43

Version: 4

Effective Time: 20220113