Zinc Oxide 20% (Zinc Oxide) Ointment [Geritrex Llc] -

ZINC OXIDE 20% (ZINC OXIDE) OINTMENT [GERITREX LLC]
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Drug Facts
Active Ingredient

Zinc Oxide 20%
Purpose

Skin Protectant
Uses
- helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.
- dries the oozing and weeping of, poison ivy, poison oak and poison sumac
Warnings

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if condition worsens or does not improve within 7 days

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.
Directions
apply liberally as often as necessary
For diaper rash:
- change wet or soiled diapers promptly
- cleanse the diaper area and allow to dry
- apply ointment liberally, as often as necessary, with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged
Other information

Store at controlled room temperature 20°-25°C (68°-77°F).
Inactive ingredients

mineral oil, petrolatum
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC OXIDE 20%
zinc oxide ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	.2 g in 1 g

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54162-040-28	28 g in 1 TUBE; Type 0: Not a Combination Product	09/17/2018
2	NDC:54162-040-56	56 g in 1 TUBE; Type 0: Not a Combination Product	09/17/2018
3	NDC:54162-040-16	454 g in 1 JAR; Type 0: Not a Combination Product	09/17/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	09/17/2018

Labeler - GERITREX LLC (112796248)

Name	Address	ID/FEI	Business Operations
Establishment
GERITREX LLC		112796248	manufacture(54162-040)

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