Otc - Active Ingredient
BUTYROSPERMUM PARKII (SHEA) BUTTER、SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL、MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
Putrizen 40 Urea Cream
FDA Label NDC 84989-025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shantou Ximonth Biotechnology Co., Ltd. for the product Putrizen 40 Urea (NDC 84989-025). 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, otc - when using, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, 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
1. Helps soften thick, rough, and hardened skin. 2. Gently exfoliates dry, flaky, and uneven texture. 3. Helps improve the appearance of cracked heels and calluses. 4. Moisturizes deeply to leave skin feeling smoother and softer. 5. With salicylic acid, lactic acid, and ceramides to support smoother-looking skin.
Otc - When Using
Use on feet, heels, elbows, knees, or other rough areas. Wash hands after use.
Warnings
For external use only. Avoid contact with eyes. Do not use on broken, irritated, or sensitive skin. Discontinue use if irritation or rash occurs. Keep out of reach of children. Do not swallow.
Otc - Do Not Use
Do not use on broken, irritated, or sensitive skin.
Otc - Stop Use
Do not use on broken, irritated, or sensitive skin.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Storage And Handling
Store in a cool and dry place.
Inactive Ingredient
UREA、WATER、GLYCERIN、PROPYLENE GLYCOL、LACTIC ACID、CETEARYL ALCOHOL、CAPRYLIC/CAPRIC TRIGLYCERIDE、SALICYLIC ACID、GLYCERYL STEARATE、PEG-100 STEARATE、CERAMIDE COMPLEX、PHENOXYETHANOL、ETHYLHEXYLGLYCERIN、PANTHENOL、ALLANTOIN、BISABOLOL、CARBOMER、 SODIUM HYALURONATE、SODIUM HYDROXIDE
Indications & Usage
Use on feet, heels, elbows, knees, or other rough areas. Wash hands after use.
Dosage & Administration
Use on feet, heels, elbows, knees, or other rough areas. Wash hands after use.
Package Label.Principal Display Panel
Label (Dsku 00001965)
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