COLD SORE RELIEF- stellaria media, salvia officinalis, calendula officials, st. johns wort, rosemary oil, plantago major, commiphora myrrha, comfrey leaf, salvia officinalis, sunflower oil salve

Cold Sore Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Purpose Section

Skin Protectant

Astringent

External Analgesic

OTC 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)

Organic Achillea Millefofolium (Yarrow) Extract 1X (HPUS)
Commiphora Myrrha (Myrrh) Resin 1X (HPUS)
Organic Salvia Officinalis (Sage) Leaf 1X (HPUS)
Organic Hypericum Perforatum (St. Johns Wort) Oil 1X (HPUS)

Indications & Uses

temporarily protects minor cold sores fever blisters

temporarily protects and helps relieve chapped or cracked lips
helps protect from the drying effects of wind and cold weather

temporarily protects and helps relieve minor skin irritation and itching due to cold sores fever blisters

temporarily protects and helps relieves minor pain associated with cold sores fever blisters

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 and Handling

Store at room temperature.

Dosage & Administration Section

Apply as often as needed to affected area.

Inactive Ingredients

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

COLD SORE RELIEF 
stellaria media, salvia officinalis, calendula officials, 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: 70994-105
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 19.8 g
ST. JOHN'S WORT (UNII: UFH8805FKA) (ST. JOHN'S WORT - UNII:UFH8805FKA)	ST. JOHN'S WORT	1 [hp_X]  in 19.8 g
STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR)	STELLARIA MEDIA	1 [hp_X]  in 19.8 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X]  in 19.8 g
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	1 [hp_X]  in 19.8 g
COMMIPHORA MYRRHA WHOLE (UNII: UU81N77RI7) (COMMIPHORA MYRRHA WHOLE - UNII:UU81N77RI7)	COMMIPHORA MYRRHA WHOLE	1 [hp_X]  in 19.8 g
SALVIA OFFICINALIS WHOLE (UNII: M9C36LC10E) (SALVIA OFFICINALIS WHOLE - UNII:M9C36LC10E)	SALVIA OFFICINALIS WHOLE	1 [hp_X]  in 19.8 g
COMFREY LEAF (UNII: DG4F8T839X) (COMFREY LEAF - UNII:DG4F8T839X)	COMFREY LEAF	1 [hp_X]  in 19.8 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
MELISSA OFFICINALIS (UNII: YF70189L0N)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)
LAVENDER OIL (UNII: ZBP1YXW0H8)
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
LARREA TRIDENTATA LEAF (UNII: PK0TXD049P)
ROSEMARY OIL (UNII: 8LGU7VM393)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70994-105-09	1 in 1 BOX	04/02/2019
1	NDC: 70994-105-01	19.8 g in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/02/2019

Labeler - Sierra Sage Herbs LLC (006970452)