COOL MINT LIP BALM- calendula officials flowers salve

Cool Mint Lip Balm by

Drug Labeling and Warnings

Cool Mint Lip Balm 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

Active Ingredients

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

Indications & Usage

■ temporarily helps protect 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 irritations due to

■ chafing ■ redness ■ windburn ■ sun exposure

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 conditions 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 Olea Europaea (Olive) Fruit Oil, Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Cera Alba (Beeswax), Organic Cocos Nucifera (Coconut) Oil, Citrus Sinensis (Orange) Fruit Extract, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Mentha Piperita (Peppermint) Oil.

Principal Display Panel

INGREDIENTS AND APPEARANCE

COOL MINT LIP BALM 
calendula officials flowers salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70994-403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X]  in 51.7 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
OLIVE OIL (UNII: 6UYK2W1W1E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
COCONUT OIL (UNII: Q9L0O73W7L)
MENTHA PIPERITA (UNII: 79M2M2UDA9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70994-403-07	4.25 g in 1 TUBE; Type 0: Not a Combination Product	02/19/2019

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)