COZIMA- zinc oxide cream

COZIMA by

Drug Labeling and Warnings

COZIMA by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)
CITRONELLA OIL (UNII: QYO8Q067D0)
COCONUT OIL (UNII: Q9L0O73W7L)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
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)

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

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

Labeler - GM Pharmaceuticals, INC (793000860)