Otc - Active Ingredient
Active ingredient Purpose
Zinc oxide 40%......................................................... Skin protectant
Goodsense Diaper Rash
FDA Label NDC 50804-779
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn, Inc. for the product Goodsense Diaper Rash (NDC 50804-779). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- helps treat and prevent diaper rash
- protects chafed skin due to diaper rash and helps seal out wetness
Warnings
Warnings
For external use only
Otc - When Using
When using this product
- do not get into eyes
Otc - Stop Use
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 right away.
Indications & Usage
Directions
- change wet and soiled diapers promptly
- cleanse the diaper area
- allow to dry
- apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Storage And Handling
Other information
- store at 20° to 25°C (68° to 77°F)
- Lot No. & Exp. Date: see box or see crimp of tube
Inactive Ingredient
Inactive ingredients butylhydroxyanisole, lavender oil, liquid paraffin, methylparaben, petrolatum, polysorbate 60, purified lanolin, sorbitan monostearate, squalane, talc, tocopherol, acetate, water
Dosage & Administration
Package Label.Principal Display Panel
Image Description (779)
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