Purpose Section
Skin Protectant
Unscented Lip Balm
FDA Label NDC 70994-405
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sierra Sage Herbs Llc for the product Unscented Lip Balm (NDC 70994-405). 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 purpose section, active ingredients, indications and usage, keep our of reach of children, warning section, storange and handling, dosage & administration, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Organic Calendula Officinalis (Calendula) Flowers 1X (HPUS)
Indications And Usage
• temporarily helps relieve • chapped or cracked lips
• helps protect from the drying effects of wind and cold weather
•temporarily protects and helps relieve minor skin irritations due to • chaffing • redness • windburn • sun exposure
• temporarily helps moisturize ª chapped and cracked lips
Keep Our Of Reach Of Children
Keep out of reach of children.
Warning Section
Warnings
For external use only.
■ Do not use on ■ deep wounds ■ animal bites ■ serious burns
■ Stop use and ask a doctor if conditions worsens symptoms last more than 7 days or clear up and occur again within a few days
■ When using this product keep out of eyes. rinse with water to remove.
Storange And Handling
Store at room temperature.
Dosage & Administration
Apply as often as needed to affected area.
Inactive Ingredients
Organic Beeswax (Cera alba), Organic Cocos nucifera (Coconut) Oil, Organic Jojoba (Simmondsia Chinensis) Oil, Organic Helianthus annuus (Sunflower) Oil, Organic Olive (Olea europaea) Oil, Tocopherols (Vitamin E) Oil.
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