baby balm

baby balm
SPL v7
SPL
SPL Set ID 48313e43-245f-5257-e054-00144ff8d46c
Route
topical
Published
Effective Date 2016-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
calendula officinalis flower (1 [hp_X]) symphytum officinale whole chamomile achillea millefolium flower
Inactive Ingredients
yellow wax alpha-tocopherol lavender oil jojoba oil olive oil sunflower oil

Identifiers & Packaging

Marketing Status
unapproved homeopathic active Since 2016-04-01

Purpose

Skin Protectant Astringent

Description

Skin Protectant Astringent


Medication Information

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.

Purpose

Skin Protectant Astringent

Inactive Ingredients

Organic Olea Europaea(Olive) Fruit Oil,Organic Cera Alba (Beeswax), Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil.

Description

Skin Protectant Astringent

Principal Display Panel

Otc Purpose

Skin Protectant

Astringent

Indications & Usage

-temporarily protects minor • diapar rash • baby acne

-helps prevent and temporarily protects and helps relieve • chapped or cracked skin

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

-temporarily protects and helps relieve minor skin irritation and itching due to • cradle cap • diaper rash • baby acne • eczema • psoriasis • rashes

Storage and Handlin

Store at room temperature.

Otc Active Ingredients

Organic Achillea Millefolium (Yarrow) Flower Extract 1X (HPUS)

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

Organic Chamomilla Recutita (Matricaria) Flower 1X (HPUS

Organic Symphytum Officinale (Comfrey) Leaf Powder 1X (HPUS)

Dosage & Administration

Apply as often as needed to the affected area.

Keep Out of Reach of Children

Keep Out of Reach of Children


Structured Label Content

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.

Inactive Ingredients

Organic Olea Europaea(Olive) Fruit Oil,Organic Cera Alba (Beeswax), Organic Helianthus Annuus (Sunflower) Seed Oil, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil.

Principal Display Panel

Otc Purpose (OTC Purpose)

Skin Protectant

Astringent

Indications & Usage

-temporarily protects minor • diapar rash • baby acne

-helps prevent and temporarily protects and helps relieve • chapped or cracked skin

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

-temporarily protects and helps relieve minor skin irritation and itching due to • cradle cap • diaper rash • baby acne • eczema • psoriasis • rashes

Storage and Handlin

Store at room temperature.

Otc Active Ingredients (OTC Active Ingredients)

Organic Achillea Millefolium (Yarrow) Flower Extract 1X (HPUS)

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

Organic Chamomilla Recutita (Matricaria) Flower 1X (HPUS

Organic Symphytum Officinale (Comfrey) Leaf Powder 1X (HPUS)

Dosage & Administration

Apply as often as needed to the affected area.

Keep Out of Reach of Children

Keep Out of Reach of Children


Advanced Ingredient Data


Raw Label Data

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