ZINC-OXYDE PLUS- zinc oxide and ferric oxide red cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z), FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)

Available from:

Randob Labs,Ltd. DBA Crossingwell Consumer Health

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Helps treat and prevent diaper rash - Protects minor skin irritation due to diaper rash and helps protect from wetness - Dries the oozing an weeping of poison ivy, oak, or sumac

Authorization status:

OTC monograph final

Summary of Product characteristics

ZINC-OXYDE PLUS- ZINC OXIDE AND FERRIC OXIDE RED CREAM
RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH
_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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ZINC-OXYDE PLUS
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_PURPOSE_
Zinc Oxide 20.6%
Skin
Protectant
Calamine 2.0%
Skin
Protectant
USES
Helps treat and prevent diaper rash
Protects minor skin irritation due to diaper rash and helps protect
from wetness
Dries the oozing an weeping of poison ivy, oak, or sumac
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. In case of accidental ingestion contact
a physician or
Poison Control Center immediately.
DIRECTIONS
Apply ointment liberally as often as necessary
For the treatment of diaper rash, change wet and soiled diapers
promptly
Cleanse the diaper area, and allow to dry
Apply with each diaper change, especially at bedtime or anytime when
exposure to
wet diapers may be prolonged.
INACTIVE INGREDIENTS
®
butylated hydroxytoluene, cetyl esters, glycerin, glycerol
monostearate, lanolin, menthol,
PEG-40 hydrogenated castor oil, phenol, sodium bicarbonate, thymol,
white petrolatum
Dist. by
CROSSINGWELL
consumer health
Box 440
Cornwall, NY 12518
PRINCIPAL DISPLAY PANEL - 57 G TUBE CARTON
Skin Irritation Relief
ZINC-OXYDE
PLUS
Zinc Oxide (skin protectant) Calamine (skin protectant)
WITH CALAMINE
MULTI PURPOSE OINTMENT
NET WT. 2 OZ. (57 g)
®
ZINC-OXYDE PLUS
zinc oxide and ferric oxide red cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:52412-775
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ZINC OXIDE (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)
Zinc Oxide
0.206 g in 1 g
FERRIC OXIDE RED (U