zinc oxide by Sion Biotext Medical Ltd / Dynarex Corporation ZINC OXIDE ointment

zinc oxide by

Drug Labeling and Warnings

zinc oxide by is a Otc medication manufactured, distributed, or labeled by Sion Biotext Medical Ltd, Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient               Purpose

Zinc Oxide (1.8% w/w)      Skin Protectant

Uses:

• Helps treat and prevent diaper rash
• Temporarily protects
  
• minor cuts
• scrapes and
• burns
• dries the oozing and weeping of
• poison ivy
• poison oak
• poison sumac
  

Warnings:

For External Use Only.

When using this product:

Do not get in eyes.

Stop use and ask a doctor if:

• condition worsens
• symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

           For skin protectant:

• Apply liberally as needed

           For diaper Rash:

• change wet and soiled diapers promptly
• allow to dry
• apply ointment liberally with each diaper change
  

Other information:

• Store at room temperature
  
• avoid excessive heat
  
• contains color additives including FDC yellow # 5
  

Principal Display Panel

Zinc Oxide Ointment

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68786-226
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIAZOLIDINYLUREA (UNII: H5RIZ3MPW4)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM BORATE (UNII: 91MBZ8H3QO)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CORN OIL (UNII: 8470G57WFM)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68786-226-01	6 in 1 CASE
1		144 in 1 BOX
1		5 g in 1 PACKET
2	NDC: 68786-226-02	6 in 1 CASE
2		36 in 1 BOX
2		15 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	02/01/2010

Labeler - Sion Biotext Medical Ltd (532775194)

Registrant - Dynarex Corporation (008124359)

Establishment
Name	Address	ID/FEI	Business Operations
Sion Biotext Medical Ltd		532775194	manufacture