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Drug Facts
Theracare Vitamin A And D Plus E Ointment
FDA Label NDC 71101-109
12 label sections · Submitted to the FDA by Veridian Healthcare · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Theracare Vitamin A And D Plus E (NDC 71101-109). 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 other, active ingredients, otc - purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Petrolatum 99.85%
Otc - Purpose
Skin Protectant
Uses
- helps treat and prevent diaper rash
- temporarily protects minor:
- cuts
- scrapes
- burns
- temporarily protects and helps relieve chapped, chafed or cracked skin and lips
- protect chafed skin due to diaper rash and helps seal out wetness
Warnings
For external use only
Do Not Use On
- deep or puncture wounds .
- animal bites
- serious burns .
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- for skin protectant use apply as needed
- for diaper rash use:
- 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 bedtime or anytime when exposure to wet diapers may be prolonged
Other Information
- store between 20°C to 25 °C ( 68° to 77°F)
- do not use if tube seal under cap is broken
Inactive Ingredients
alpha-tocopherol acetate (vitamin E), cholecalciferol (vitamin D3), medium chain triglycerides USP, retinyl palmitate(vitamin A palmitate)
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