Nursing Cream: Homeopathic Product Information

NURSING CREAM- althaea officinalis root, calendula officinalis flower and chamomile 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.

OTC Purpose

Skin Protectant

OTC Active Ingredients

Organic Calendula Officinalis (Calendula) Flower Oil 1X (HPUS)
Organic Chamomilla Recutita (Matricaria) Flower Oil 1X (HPUS)
Organic Althaea Officinalis (Marshmallow) Root 1X (HPUS)

Indications & Usage

■ temporarily protects skin related to ■ nursing ■ pregnancy

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

■ temporarily protects and helps relieve minor skin irritation

Warnings

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.

Keep Out of Reach of Children

Keep Out of Reach of Children

Storage and Handlin

Store at room temperature.

Dosage & Administration

Clean and dry nipple area before application. Apply as often as needed. Clean and dry nipple area before nursing.

Inactive Ingredients

Organic Olea Europaea (Olive) Fruit Oil, Organic Cera Alba (Beeswax).

Principal Display Panel

NURSING CREAM calendula officinalis, chamomilla recutita, althaea officinalis salve

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70994-503 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTHAEA OFFICINALIS ROOT (ALTHAEA OFFICINALIS ROOT) ALTHAEA OFFICINALIS ROOT 1 [hp_X] in 51.7 g CALENDULA OFFICINALIS FLOWER (CALENDULA OFFICINALIS FLOWER) CALENDULA OFFICINALIS FLOWER 1 [hp_X] in 51.7 g CHAMOMILE (CHAMOMILE) CHAMOMILE 1 [hp_X] in 51.7 g

Inactive Ingredients Ingredient Name Strength YELLOW WAX OLIVE OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70994-503-10 1 CAN in 1 BOX contains a CAN (70994-503-02) 1 NDC:70994-503-02 51.7 g in 1 CAN This package is contained within the BOX (70994-503-10) 2 NDC:70994-503-01 19.8 g in 1 CAN None 3 NDC:70994-503-08 113.4 g in 1 JAR None

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)

Revised: 01/2021 Sierra Sage Herbs LLC