Otc - Active Ingredient
Zinc oxide 1.1%
Rough Dry
FDA Label NDC 71157-0020
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kelada Creative Group Llc Dba Salve for the product Rough Dry (NDC 71157-0020). 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, dosage & administration, otc - keep out of reach of children, inactive ingredient, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Temporarily protects and helps relieve minor skin irritation and itching due to eczema, dermatitis, dryness, cracking, flaking, and calluses.
Warnings
For external use only
Do not use other than as directed
When using this product
- avoid contact with eyes and mucous membranes
- do not apply to wounds or bleeding skin
Dosage & Administration
Temporarily protects and helps relieve minor skin irritation and itching due to eczema, dermatitis, dryness, cracking, flaking, and calluses.
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.
Inactive Ingredient
Salicylic acid, Macadamia nut butter, Sweet almond butter, Meadowfoam seed oil, Organic avocado oil, Beeswax, Cocoa butter, Bergamot essential oil, Patchouli essential oil, Rosemary essential oil
Indications & Usage
Temporarily protects and helps relieve minor skin irritation and itching due to eczema, dermatitis, dryness, cracking, flaking, and calluses.
* Please review the disclaimer below.
