Other
Drug Facts
DISTRIBUTED BY
AMERCARE PRODUCTS, INC
Amerfresh Medicated
FDA Label NDC 51460-0504
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amercare Products Inc for the product Amerfresh Medicated (NDC 51460-0504). 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, otc - purpose, uses, warnings, otc - when using, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredients | Purpose |
|---|---|
| Menthol 0.15% | Anti-itch |
| Zinc Oxide 1.0% | Skin Protection |
Uses
temporarily relieves the pain and itch associated with:
- Minor cuts
- Sunburn
- Insect Bites
- Scrapes
- Prickly Heat
- Minor Burns
- Rashes
- Minor Skin Irritations
- Dries the oozing of poison ivy, oak and sumac.
Warnings
For external use only
Otc - When Using
- Avoid contact with eyes.
Stop Use And Ask A Doctor If
- condition worsens
- symptoms do not get better within 7 days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control right away.
Directions
| adults and children 2 years and older | apply freely up to 3 or 4 times daily |
| Children under 2 years | ask a doctor |
| For best results dry skin thoroughly before applying | |
Inactive Ingredients
Talc, Eucalyptol, Methyl salicylate, Salicylic acid, Thymol, Zinc stearate.
Principal Display Panel - 283G Container Label
AMERFRESH®
BONDED
*FOR*
PURITY
MEDICATED
BODY
POWDER
NET WT.10 OZ. (283g)
Principal Display Panel (283g Container Label)
* Please review the disclaimer below.
