Baby Balm (Calendula Officinalis, Chamomilla Recutita, Archillea Millefolium, Symphytum Officinalis, Helianthus Annuus) Salve [Sierra Sage Herbs Llc] -

BABY BALM (CALENDULA OFFICINALIS, CHAMOMILLA RECUTITA, ARCHILLEA MILLEFOLIUM, SYMPHYTUM OFFICINALIS, HELIANTHUS ANNUUS) SALVE [SIERRA SAGE HERBS LLC]
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NDC	70994-501-02, 70994-501-04, 70994-501-08, 70994-501-10
Set ID	48313e43-245f-5257-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	Sierra Sage Herbs LLC
Generic Name
Product Class
Product Number
Application Number

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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.
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INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X] in 51.7 g
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y)	SYMPHYTUM OFFICINALE WHOLE	1 [hp_X] in 51.7 g
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	1 [hp_X] in 51.7 g
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) (ACHILLEA MILLEFOLIUM FLOWER - UNII:YQR8R0SQEA)	ACHILLEA MILLEFOLIUM FLOWER	1 [hp_X] in 51.7 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
LAVENDER OIL (UNII: ZBP1YXW0H8)
JOJOBA OIL (UNII: 724GKU717M)
OLIVE OIL (UNII: 6UYK2W1W1E)
SUNFLOWER OIL (UNII: 3W1JG795YI)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70994-501-10	1 in 1 BOX	04/01/2016
1	NDC:70994-501-02	51.7 g in 1 CAN; Type 0: Not a Combination Product
2	NDC:70994-501-04	17 g in 1 TUBE; Type 0: Not a Combination Product	02/06/2019
3	NDC:70994-501-08	113.4 g in 1 JAR; Type 0: Not a Combination Product	04/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/01/2016

Labeler - Sierra Sage Herbs LLC (006970452)

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Medic

BABY BALM (CALENDULA OFFICINALIS, CHAMOMILLA RECUTITA, ARCHILLEA MILLEFOLIUM, SYMPHYTUM OFFICINALIS, HELIANTHUS ANNUUS) SALVE [SIERRA SAGE HERBS LLC]

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