COZIMA- zinc oxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

GM Pharmaceuticals, INC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant - helps treat and prevent diaper rash - protects chafed skin due to diaper rash and helps seal out wetness

Authorization status:

OTC monograph final

Summary of Product characteristics

COZIMA- ZINC OXIDE CREAM
GM PHARMACEUTICALS, INC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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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)
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
GM Pharmaceuticals, INC
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
24 g