BELLY BALM- rosehip seed oil salve

Belly Balm by

Drug Labeling and Warnings

Belly 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)

Organic Rosa Canina (Rosehip) Seed Extract 3.3%

Indications & Usage

■ temporarily protects minor ■ itchy skin ■ pregnant belly skin ■ stretch marks

■ helps prevent and temporarily protects and helps relieve ■ chapped or cracked skin

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

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 pregnant belly.

Inactive Ingredients

Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax), Organic Simmondsia Chinensis (Jojoba) Seed Oil, Organic Butyrospermum Parkii (Shea) Butter, Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Theobroma Cacao (Cocoa) Seed Butter, Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil.

Principal Display Panel

INGREDIENTS AND APPEARANCE

BELLY BALM 
rosehip seed oil salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70994-506
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ROSA MOSCHATA OIL (UNII: J99W255AWF) (ROSA MOSCHATA OIL - UNII:J99W255AWF)	ROSA MOSCHATA OIL	3.3 g  in 100 g
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD)	CALENDULA OFFICINALIS FLOWER	1 [hp_X]  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
LAVENDER OIL (UNII: ZBP1YXW0H8)
COCOA BUTTER (UNII: 512OYT1CRR)
YELLOW WAX (UNII: 2ZA36H0S2V)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
OLIVE OIL (UNII: 6UYK2W1W1E)
SUNFLOWER OIL (UNII: 3W1JG795YI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70994-506-10	1 in 1 BOX	07/09/2019
1	NDC: 70994-506-02	51.7 g in 1 CAN; Type 0: Not a Combination Product
2	NDC: 70994-506-08	113.4 g in 1 JAR; Type 0: Not a Combination Product	07/09/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/09/2019

Labeler - Sierra Sage Herbs LLC (006970452)