SALVACINE- calendula officials, plantago major, olea europaea, achillea millefolium 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.

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Salvacine Homeopathic Salve

Purpose Section

Skin Protectant

Astringent

Active Ingredients

Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)
Organic Plantago Major (Plantain) Leaf Extract 1X (HPUS)

Organic Olea Europaea (Olive) Leaf Oil 1X (HPUS)

OrganicAchilleaMillefolium(Yarrow)Extract1X(HPUS)

Indications & Usage

• temporarily protects minor • cuts • scrapes • abrasions • bruises • blisters • burns

▪︎ 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 irritations and itching due to • cracked hands and cracked feet • minor rashes • rashes caused by soaps, detergents, cosmetics, or jewelry

Keep out of reach of children section

Keep out of reach of children.

Warnings Section

Warnings

For external use only.

• Do not use 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.

Storage

Store at room temperature.

Dosage & Administration Section

• clean affected area • Apply as often as needed • can be covered with strile bandage

Inactive Ingredients

Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax), Organic Ricinus Communis (Castor) Seed Oil, Lavandula Angustifolia (Lavender) Oil, Tocopherol (Vitamin E), Rosmarinus Officinalis (Rosemary) Leaf Oil.

Principal Display Panel

Salvacine

SALVACINE
calendula officials, plantago major, olea europaea, achillea millefolium salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70994-801
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) (OLEA EUROPAEA LEAF - UNII:MJ95C3OH47)	OLEA EUROPAEA LEAF	1 [hp_X] in 100 g
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) (ACHILLEA MILLEFOLIUM FLOWER - UNII:YQR8R0SQEA)	ACHILLEA MILLEFOLIUM FLOWER	1 [hp_X] in 100 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X] in 100 g
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	1 [hp_X] in 100 g

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ROSEMARY OIL (UNII: 8LGU7VM393)
LAVENDER OIL (UNII: ZBP1YXW0H8)
OLIVE OIL (UNII: 6UYK2W1W1E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70994-801-10	1 in 1 BOX	08/29/2022
1	NDC:70994-801-02	51.7 g in 1 CAN; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/29/2022

Labeler - Sierra Sage Herbs LLC (006970452)

Revised: 8/2022

Document Id: e77adb0c-82eb-597b-e053-2a95a90a2d95

Set id: e76594d6-7397-5d57-e053-2a95a90a99af

Version: 2

Effective Time: 20220830

Sierra Sage Herbs LLC