Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 829e6da3-84eb-3a28-e053-2991aa0ac0a2
Route
TOPICAL
Published
Effective Date 2019-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (3.1545 g)
Inactive Ingredients
Panthenol Squalene Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-02-24

Description

glycerin


Medication Information

Warnings and Precautions

for external use only

do not use if sensitive to any of the ingredients

discontinue use if signs of irritation or rash appear

if irritation or rash persists, contact a doctor

Indications and Usage

Gently massage into skin as often as needed

Dosage and Administration

for external use only

Description

glycerin

Section 50565-1

keep out of reach of the children

Section 51727-6

Camellia Japonica Flower Extract

Caprylic/Capric Triglyceride

Glycerin

Water(Aqua)

Pentylene Glycol

Camellia Japonica Seed Oil

Propanediol

Hydrogenated Palm Kernel Oil

Phosphatidylcholine

Phytosteryl Macadamiate

Butyrospermum Parkii (Shea) Butter

Mangifera Indica (Mango) Seed Butter

Xanthan Gum

Panthenol

Camellia Sinensis Leaf Extract

Chamomilla Recutita (Matricaria) Leaf Extract

Thujopsis Dolabrata Branch Extract

Sorbitan Caprylate

Arginine

Squalane

Trehalose

Magnolia Kobus Bark Extract

Salix Alba (Willow) Bark Extract

Dipotassium Glycyrrhizate

Centella Asiatica Extract

Dimethyl Sulfone

Hizikia Fusiforme Extract

Glycyrrhiza Glabra (Licorice) Root Extract

Yeast Beta-Glucan

Levulinic Acid

Betaine

Houttuynia Cordata Extract

Portulaca Oleracea Extract

Hyaluronic Acid

Aloe Barbadensis Leaf Extract

Olea Europaea (Olive) Fruit Oil

Citrus Unshiu Peel Extract

Opuntia Ficus-Indica Fruit Extract

Polygonum Cuspidatum Root Extract

Scutellaria Baicalensis Root Extract

Vitis Vinifera (Grape) Skin Extract

Tocopherol

Pyrus Malus (Apple) Fruit Extract

Rosmarinus Officinalis (Rosemary) Leaf Extract

Silybum Marianum Extract

Vaccinium Angustifolium (Blueberry) Fruit Extract

Bioflavonoids

Bisabolol

Rosa Canina Fruit Oil

Brassica Oleracea Italica (Broccoli) Extract

Linoleic Acid

Rutin

Astaxanthin

Quercetin

Aniba Rosodora (Rosewood) Wood Oil

Jasminum Sambac (Jasmine) Flower Extract

Lavandula Angustifolia (Lavender) Oil

Rosmarinus Officinalis (Rosemary) Leaf Oil

Section 51945-4

Section 55105-1

suitable for delicate baby's skin

soothes and protects sensitive skin

Section 55106-9

glycerin


Structured Label Content

Indications and Usage (34067-9)

Gently massage into skin as often as needed

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

for external use only

do not use if sensitive to any of the ingredients

discontinue use if signs of irritation or rash appear

if irritation or rash persists, contact a doctor

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Camellia Japonica Flower Extract

Caprylic/Capric Triglyceride

Glycerin

Water(Aqua)

Pentylene Glycol

Camellia Japonica Seed Oil

Propanediol

Hydrogenated Palm Kernel Oil

Phosphatidylcholine

Phytosteryl Macadamiate

Butyrospermum Parkii (Shea) Butter

Mangifera Indica (Mango) Seed Butter

Xanthan Gum

Panthenol

Camellia Sinensis Leaf Extract

Chamomilla Recutita (Matricaria) Leaf Extract

Thujopsis Dolabrata Branch Extract

Sorbitan Caprylate

Arginine

Squalane

Trehalose

Magnolia Kobus Bark Extract

Salix Alba (Willow) Bark Extract

Dipotassium Glycyrrhizate

Centella Asiatica Extract

Dimethyl Sulfone

Hizikia Fusiforme Extract

Glycyrrhiza Glabra (Licorice) Root Extract

Yeast Beta-Glucan

Levulinic Acid

Betaine

Houttuynia Cordata Extract

Portulaca Oleracea Extract

Hyaluronic Acid

Aloe Barbadensis Leaf Extract

Olea Europaea (Olive) Fruit Oil

Citrus Unshiu Peel Extract

Opuntia Ficus-Indica Fruit Extract

Polygonum Cuspidatum Root Extract

Scutellaria Baicalensis Root Extract

Vitis Vinifera (Grape) Skin Extract

Tocopherol

Pyrus Malus (Apple) Fruit Extract

Rosmarinus Officinalis (Rosemary) Leaf Extract

Silybum Marianum Extract

Vaccinium Angustifolium (Blueberry) Fruit Extract

Bioflavonoids

Bisabolol

Rosa Canina Fruit Oil

Brassica Oleracea Italica (Broccoli) Extract

Linoleic Acid

Rutin

Astaxanthin

Quercetin

Aniba Rosodora (Rosewood) Wood Oil

Jasminum Sambac (Jasmine) Flower Extract

Lavandula Angustifolia (Lavender) Oil

Rosmarinus Officinalis (Rosemary) Leaf Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

suitable for delicate baby's skin

soothes and protects sensitive skin

Section 55106-9 (55106-9)

glycerin


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