ENDIT ZINC OXIDE SKIN PROTECTANT- zinc oxide ointment

Endit Zinc Oxide Skin Protectant by

Drug Labeling and Warnings

Endit Zinc Oxide Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Endit Laboratories, Inc., Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Zinc Oxide 20.00%

Purpose:

Skin Protectant

Uses:

Helps treat and prevent rash associated with diaper use, incontinence, or exposure to feces and urine. Protects chafed skin due to diaper rash and helps seal out wetness.

Warnings:

For external use only.

When using this product do not get in eyes.

Stop use and ask 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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• Change wet and soiled diapers promptly.
• Cleanse the diaper area (perineum, buttocks, lower abdomen, and inner thighs), and allow to dry.
• Apply liberally as often as necessary with each diaper change, especially at bedtime or anytime when exposure to soiled dapers (feces, and/or urine) may be prolonged.

Other Ingredients:

Boric Acid, Calamine, Cornstarch, Juniper Tar, Lanolin, Resorcinol, White Petrolatum

Package Labeling:

INGREDIENTS AND APPEARANCE

ENDIT ZINC OXIDE SKIN PROTECTANT 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64068-402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STARCH, CORN (UNII: O8232NY3SJ)
JUNIPER TAR (UNII: 1Q84T0P2G3)
LANOLIN (UNII: 7EV65EAW6H)
RESORCINOL (UNII: YUL4LO94HK)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64068-402-01	454 g in 1 JAR; Type 0: Not a Combination Product	05/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/31/2017

Labeler - Endit Laboratories, Inc. (065285207)

Establishment
Name	Address	ID/FEI	Business Operations
Kalchem International Inc.		805294014	manufacture(64068-402) , label(64068-402) , pack(64068-402)