ZINC-OXYDE PLUS by Randob Labs,Ltd. DBA Crossingwell Consumer Health ZINC-OXYDE PLUS®

ZINC-OXYDE PLUS by

Drug Labeling and Warnings

ZINC-OXYDE PLUS by is a Otc medication manufactured, distributed, or labeled by Randob Labs,Ltd. DBA Crossingwell Consumer Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675)	FERRIC OXIDE RED	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL ESTERS WAX (UNII: D072FFP9GU)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LANOLIN (UNII: 7EV65EAW6H)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
PHENOL (UNII: 339NCG44TV)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
THYMOL (UNII: 3J50XA376E)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Product Characteristics
Color	PINK (White to light pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52412-775-02	57 g in 1 TUBE; Type 0: Not a Combination Product	03/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	03/30/2022

Labeler - Randob Labs,Ltd. DBA Crossingwell Consumer Health (061995007)

Revised: 4/2022

Document Id: 0412afd6-c575-44ec-b40b-a1da2bffb5e2

34390-5

Set id: 3d0233ac-57da-4c63-8922-00517ccb799c

Version: 1

Effective Time: 20220406

 

Randob La