Hand Care by Sierra Sage Herbs LLC Hand Care

Hand Care by

Drug Labeling and Warnings

Hand Care by is a Homeopathic medication manufactured, distributed, or labeled by Sierra Sage Herbs LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND CARE- calendula officials, stellaria media, st. johns wort, rosemary oil, plantago major, commiphora myrrha, comfrey leaf, salvia officinalis, sunflower oil 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.

----------

Hand Care

Purpose Section

Skin Protectant

Astringent

External Analgesic

Active Ingredients

Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)
Organic Plantago Major (Plantain) Leaf Extract 1X (HPUS)
Organic Stellaria Media (Chickweed) Extract 1X (HPUS)
Organic Symphytum Officinale (Comfrey) Leaf Powder 1X (HPUS)

OrganicAchilleaMillefolium(Yarrow)Extract1X(HPUS)

Commiphora Myrrha (Myrrh) Resin 1X (HPUS)

Organic Salvia Officinalis (Sage) Leaf 1X (HPUS)
Organic Hypericum Perforatum (St. John’s Wort) Oil 1X (HPUS).

Indications & Usage

-temporarily protects minor cuts scrapes abrasions blisters burns

-helps prevent and temporarily protects and helps relieve cracked skin and heels

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

-Temporarily protects and helps relieve minor skin irritation and itching due to itchy rashes poison ivy insect bites rashes caused by soaps, detergents, cosmetics, or jewelry

-temporarily protects and helps relieve minor pain associated with calluses blisters abrasions bruises cuts minor burns scrapes

Keep out of reach of children section

Keep out of reach of children.

Warnings Section

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.

Storage

Store at room temperature.

Dosage & Administration Section

Apply as often as needed to affected area.

Inactive Ingredients

Organic Cera Alba (Beeswax),Organic Helianthus Annuus (Sunflower) Seed Oil, Hemp (Hemp) Oil, Organic Larrea Tridentata (Chapparal) Extract, Lavandula Angustifolia (Lavender) Oil, Organic Olea Europaea (Olive) Fruit Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Styrax Benzoin Gum, Tocopherol (Vitamin E).

Principal Display Panel

HAND CARE 
calendula officials, stellaria media, st. johns wort, rosemary oil, plantago major, commiphora myrrha, comfrey leaf, salvia officinalis, sunflower oil salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70994-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) (ACHILLEA MILLEFOLIUM FLOWER - UNII:YQR8R0SQEA)	ACHILLEA MILLEFOLIUM FLOWER	1 [hp_X]  in 51.7 g
ST. JOHN'S WORT (UNII: UFH8805FKA) (ST. JOHN'S WORT - UNII:UFH8805FKA)	ST. JOHN'S WORT	1 [hp_X]  in 51.7 g
STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR)	STELLARIA MEDIA	1 [hp_X]  in 51.7 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X]  in 51.7 g
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	1 [hp_X]  in 51.7 g
COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7) (COMMIPHORA MYRRHA WHOLE - UNII:UU81N77RI7)	COMMIPHORA MYRRHA WHOLE	1 [hp_X]  in 51.7 g
SALVIA OFFICINALIS WHOLE (UNII: M9C36LC10E) (SALVIA OFFICINALIS WHOLE - UNII:M9C36LC10E)	SALVIA OFFICINALIS WHOLE	1 [hp_X]  in 51.7 g
COMFREY LEAF (UNII: DG4F8T839X) (COMFREY LEAF - UNII:DG4F8T839X)	COMFREY LEAF	1 [hp_X]  in 51.7 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
LARREA TRIDENTATA LEAF (UNII: PK0TXD049P)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
ROSEMARY OIL (UNII: 8LGU7VM393)
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)
LAVENDER OIL (UNII: ZBP1YXW0H8)
OLIVE OIL (UNII: 6UYK2W1W1E)
HEMP (UNII: TD1MUT01Q7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70994-701-04	17 g in 1 TUBE; Type 0: Not a Combination Product	07/25/2019	08/10/2019
2	NDC: 70994-701-09	1 in 1 BOX	07/25/2019	08/10/2019
2	NDC: 70994-701-01	19.8 g in 1 CAN; Type 0: Not a Combination Product
3	NDC: 70994-701-15	1 in 1 BOX	07/25/2019	08/10/2019
3	NDC: 70994-701-14	1.82 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/25/2019	08/10/2019

Labeler - Sierra Sage Herbs LLC (006970452)

Revised: 8/2019

Document Id: 8fc68ef5-d3f7-9296-e053-2995a90adb6c

34390-5

Set id: 8e9b8a75-2d90-a1cf-e053-2a95a90a300d

Version: 2

Effective Time: 20190810

 

Sierra Sage Herbs LLC