Thera Plus Vitamin A And D Cream
FDA Label NDC 80684-135
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fourstar Group Usa, Inc. for the product Thera Plus Vitamin A And D Cream (NDC 80684-135). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, ask a doctor before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Dimethicone 1%
Zinc oxide 10%
Purpose
Skin protectant
Uses
- helps prevent diaper rash
- heals dry, flaky and chafed skin
- soothes and protects minor cuts and burns
Warnings
For external use only.
Do Not Use
- over large areas of the body
- not for extensive burns or serious cuts, consult a physician
When Using This Product
- avoid contact with eyes
Ask A Doctor Before Use
- serious burns
- deep wounds
Stop Use And Ask A Doctor If
- symptoms last for more than 7 days
- redness, irritation, swelling or pain persists or increases or if infection develops.
- symptoms clear up and then 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 (1-800-222-1222).
Directions
- Adults and children 2 years of age and older: apply generously and massage until absorbed. Repeat as necessary
- children under 2 years of age: ask a doctor before use
Other Information
store at room temperature 68° - 72°F (20° - 22°C).
Inactive Ingredients
cod liver oil, vitamin E, white petrolatum
Questions?
1-800-639-3803Weekdays 9 AM to 4 PM EST
Package Label:
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