ELIXIRZINCOCARE- zinc oxide 20% ointment

ElixirZincoCare by

Drug Labeling and Warnings

ElixirZincoCare by is a Otc medication manufactured, distributed, or labeled by ELIXIR HEALTHCARE USA, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each gram)

Zinc Oxide 20% w/w

Purpose

First Aid Antibiotic

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

Do not use

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

Ask a doctor before use in case of

deep or puncture wounds
animal bites
serious burns

Stop use and ask a doctor if

condition persists or gets worse
a rash or other allergic reaction develops

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

Inactive ingredients

Cetostearyl Alcohol, Cetomacrogol-1000, Lanoline Anhydrous, White Petroleum Jelly, Light Liquid Paraffin

Other information

Store at USP controlled room temperature 20-25°C (68-77°F)
To open: unscrew cap, remove liner seal and replace cap.
see carton or tube crimp for lot number and expiration date

PRINCIPAL DISPLAY PANEL

Zinc Oxide Ointment

Skin Protectant 2 oz

Reorder No. xxxx

Individually Boxed 12 Tubes per Pack

Each Tube Net Weight 2 oz

Gross Wt. 5.300 kg Net Wt. 4.075 kg

72 Tubes

Elixir

PRINCIPAL DISPLAY PANEL

Zinc Oxide Ointment

Skin Protectant 1 oz

Net Wt. 1 OZ (28.3 g)

Reorder No. xxxx

Elixir

PRINCIPAL DISPLAY PANEL

ZINC OXIDE OINTMENT

ZINC OXIDE 20%

Skin Protectant

15 OZ. Jars 12 Jars per Case

Reorder No.: ______

INGREDIENTS AND APPEARANCE

ELIXIRZINCOCARE 
zinc oxide 20% ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84546-0004
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84546-0004-1	1 in 1 CARTON	12/31/2025
1		28.3 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 84546-0004-2	6 in 1 CASE	12/31/2025
2		12 in 1 BOX
2		56.7 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 84546-0004-3	454 g in 1 JAR; Type 0: Not a Combination Product	12/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	12/31/2025

Labeler - ELIXIR HEALTHCARE USA, LLC. (084920892)