Zinc Oxide by Geri-Gentle Corporation ZINC OXIDE ointment

Zinc Oxide by

Drug Labeling and Warnings

Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Geri-Gentle Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide (20%w/w)

Purpose

Skin Protectant

Uses

• helps treat and prevent diaper rash
• dries the oozing and weeping of:
  • poison ivy
  • poison oak
  • poison sumac

Warnings

For external use only

When using this product

• do not get into eyes
• do not use over large area of the body

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
• if you are allergic to any of these ingredients

Do not use on

• deep puncture wounds
• animal bites
• serious burns

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 diaper promptly
• cleanse the diaper area and allow to dry
• apply as needed

Other information

• store at 59°-86°F (15°-30°C)
• avoid excessive heat

Inactive Ingredients

Cetostearyl Alcohol, Cetomacrogol 1000, Light Liquid Paraffin, White Soft Paraffin

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Box

GeriGentle

Zinc Oxide Ointment
SKIN PROTECTANT 1 oz

Net Wt. 1oz. (28.4g)

Reorder No.
16-720

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69771-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69771-109-38	1 in 1 BOX	01/15/2017
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69771-109-39	1 in 1 BOX	01/15/2017
2		56.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/15/2017

Labeler - Geri-Gentle Corporation (361663839)