Otc Purpose
Skin Protectant
Astringent
Baby Balm Salve
FDA Label NDC 70994-501
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spry Life Llc for the product Baby Balm (NDC 70994-501). 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 purpose, otc active ingredients, indications & usage, warnings, keep out of reach of children, storage and handlin, dosage & administration, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc Active Ingredients
Organic Calendula Officinalis (Calendula) Flowers 1X (HPUS)
Organic Chamomilla Recutita (Chamomile) Flowers 1X (HPUS)
Organic Symphytum Officinalis (Comfrey) 1X (HPUS)
Organic Achillea Millefolium (Yarrow) 1X (HPUS)
Indications & Usage
-temporarily relieves symptoms related to • cradle cap • baby acne • diaper rash
-helps to moisturize dry skin head to toe
-temporarily helps to protect and relieve pain and redness due to •diaper rash • baby acne • eczema • psoriasis
Warnings
Warnings For external use only.
-Don’t use on damaged or broken skin.
-When using this product keep out of eyes. Rinse with water to remove.
-Stop using and ask a doctor if rash or irritation occurs.
Keep Out Of Reach Of Children
Keep Out of Reach of Children
Storage And Handlin
Store at room temperature.
Dosage & Administration
Apply as often as needed to the affected area.
Inactive Ingredients
Organic Cera Alba (Beeswax), Organic Helianthus Annuus (Sunflower) Oil,
Lavandula Angustifolia (Lavender) Essential Oil, Organic Olea europaea (Olive)
Oil, Organic Simmondsia Chinensis (Jojoba) Oil, Non-GMO (100% Sunflower)
Mixed Tocopherols (Vitamin E).
* Please review the disclaimer below.
