zinc oxide 20% by Bionpharma Inc / Bionpharma Inc. / Galentic Pharma (India) Private Limited ZINC OXIDE 20% ointment

zinc oxide 20% by

Drug Labeling and Warnings

zinc oxide 20% by is a Otc medication manufactured, distributed, or labeled by Bionpharma Inc, Bionpharma Inc., Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide 20 %

Purpose

Skin Protectant

Uses

■ Dries the oozing and weeping of poison ivy oak sumac
■ Helps treat and prevent diaper rash
■ Protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

When using this product

do not get into 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.

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

Directions

■ For poison ivy, oak & sumac: apply as needed

■ For Diaper Rash

• Change wet and soiled diapers promptly
• Cleanse the diaper area and allow to dry
• Apply ointment liberally as often as necessary, with each diaper change, especially at bed time or anytime when exposure to wet diapers may be prolonged

Other information

■ Store at 15°C – 30°C (59°F – 86°F)

Inactive ingredients

ceteareth 20, cetostearyl alcohol, light mineral oil, white petrolatum

SPL UNCLASSIFIED SECTION

Manufactured for:
Bionpharma Inc.
Princeton, NJ 08540
MADE IN INDIA

L0000798

KBP0581L-0

R0324
GUJ/DRUGS/G/25/2134

PRINCIPAL DISPLAY PANEL

NDC: 69452-450-58

dye-free paraben-free

phthalate-free fragrance-free

a+ health TM

healing ointment

zinc oxide 20% / skin protectant
protects chafed skin due to diaper rash and helps seal out wetness
dries the oozing and weeping of poison ivy, oak and sumac

net wt. 15 oz

INGREDIENTS AND APPEARANCE

ZINC OXIDE 20% 
zinc oxide 20% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69452-450
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
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69452-450-58	425 g in 1 JAR; Type 0: Not a Combination Product	04/18/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/01/2024

Labeler - Bionpharma Inc (079637826)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	manufacture(69452-450)