Baby Balm: Homeopathic Product Information

BABY BALM- calendula officinalis flower, symphytum officinale whole, chamomile and achillea millefolium flower salve
Sierra Sage Herbs LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

OTC Purpose

Skin Protectant

Astringent

OTC Active Ingredients

Organic Achillea Millefolium (Yarrow) Flower Extract 1X (HPUS)

Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)

Organic Chamomilla Recutita (Matricaria) Flower 1X (HPUS
Organic Symphytum Officinale (Comfrey) Leaf Powder 1X (HPUS)

Indications & Usage

-temporarily protects minor • diapar rash • baby acne

-helps prevent and temporarily protects and helps relieve • chapped or cracked skin

-helps protect from the drying effects of wind and cold weather

-temporarily protects and helps relieve minor skin irritation and itching due to • cradle cap • diaper rash • baby acne • eczema • psoriasis • rashes

Warnings

Warnings

For external use only.

-Do not use on • on deep wounds • animal bites • serious burns

-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

-When using this product keep out of eyes. Rinse with water to remove.

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 Olea Europaea(Olive) Fruit Oil,Organic Cera Alba (Beeswax), Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil.

Principal Display Panel

Baby Balm
(click image for full-size original)

BABY BALM
calendula officinalis, chamomilla recutita, archillea millefolium, symphytum officinalis, helianthus annuus salve
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70994-501
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALENDULA OFFICINALIS FLOWER (CALENDULA OFFICINALIS FLOWER) CALENDULA OFFICINALIS FLOWER 1 [hp_X] in 51.7 g
SYMPHYTUM OFFICINALE WHOLE (SYMPHYTUM OFFICINALE WHOLE) SYMPHYTUM OFFICINALE WHOLE 1 [hp_X] in 51.7 g
CHAMOMILE (CHAMOMILE) CHAMOMILE 1 [hp_X] in 51.7 g
ACHILLEA MILLEFOLIUM FLOWER (ACHILLEA MILLEFOLIUM FLOWER) ACHILLEA MILLEFOLIUM FLOWER 1 [hp_X] in 51.7 g
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX
ALPHA-TOCOPHEROL
LAVENDER OIL
JOJOBA OIL
OLIVE OIL
SUNFLOWER OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70994-501-10 1 CAN in 1 BOX contains a CAN (70994-501-02)
1 NDC:70994-501-02 51.7 g in 1 CAN This package is contained within the BOX (70994-501-10)
2 NDC:70994-501-04 17 g in 1 TUBE None
3 NDC:70994-501-08 113.4 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 04/01/2016
Labeler — Sierra Sage Herbs LLC (006970452)

Revised: 01/2021 Sierra Sage Herbs LLC

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