COZIMA- zinc oxide cream 
GM Pharmaceuticals, INC

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COZIMA

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)

PRINCIPAL DISPLAY PANEL
NDC 58809-450-04
COZIMA
DIAPER RASH CREAM
Zinc Oxide
Skin Protectant
NET Wt 4 OZ (113 g)

COZIMA 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-450
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
TEA TREE OIL (UNII: VIF565UC2G)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-450-04113 g in 1 BOTTLE; Type 0: Not a Combination Product10/01/201801/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01610/01/201801/01/2023
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 11/2023
 
GM Pharmaceuticals, INC