Active Ingredient (In Each Gram)
Zinc Oxide 20% w/w
Elixirzincocare Ointment
FDA Label NDC 84546-0004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Elixir Healthcare Usa, Llc. for the product Elixirzincocare (NDC 84546-0004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each gram), purpose, uses, warnings, do not use, ask a doctor before use in case of, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Zinc Oxide Ointment
Skin Protectant • 1 oz
Net Wt. 1 OZ (28.3 g)
Reorder No. xxxx
Elixir
Tube Lable.jpg (Box Label3)
ZINC OXIDE OINTMENT
ZINC OXIDE 20%
Skin Protectant
15 OZ. Jars • 12 Jars per Case
Reorder No.: ______
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