Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 829d20e1-aad9-5151-e053-2a91aa0a85f3
Route
TOPICAL
Published
Effective Date 2019-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (1.9345 g)
Inactive Ingredients
Panthenol Citric Acid Acetate 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

Wet baby's skin and hair with warm water. Gently massage over entire body and scalp, then rinse thoroughly.

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

Disodium Cocoamphodiacetate

Lauryl Glucoside

Sodium Lauroyl Glutamate

Glycerin

Pentylene Glycol

Citric Acid

Sorbitan Caprylate

Panthenol

Propanediol

Trehalose

Water(Aqua)

Centella Asiatica Extract

Dipotassium Glycyrrhizate

Dimethyl Sulfone

Portulaca Oleracea Extract

Hizikia Fusiforme Extract

Glycyrrhiza Glabra (Licorice) Root Extract

Houttuynia Cordata Extract

Coptis Japonica Root Extract

Yeast Beta-Glucan

Betaine

Hyaluronic Acid

Aloe Barbadensis Leaf Extract

Levulinic Acid

Olea Europaea (Olive) Fruit Oil

Camellia Sinensis Leaf Extract

Opuntia Ficus-Indica Fruit Extract

Polygonum Cuspidatum Root Extract

Scutellaria Baicalensis Root Extract

Camellia Japonica Seed Oil

Rosmarinus Officinalis (Rosemary) Leaf Extract

Tocopherol

Bioflavonoids

Chamomilla Recutita (Matricaria) Leaf Extract

Bisabolol

Rosa Canina Fruit Oil

Brassica Oleracea Italica (Broccoli) Extract

Michelia Alba Flower Oil

Rose Flower Oil

Cananga Odorata Flower Oil

Section 51945-4

Section 55105-1

protect the skin from dryness and irritation while leaving baby's skin clean and fresh

Section 55106-9

glycerin


Structured Label Content

Indications and Usage (34067-9)

Wet baby's skin and hair with warm water. Gently massage over entire body and scalp, then rinse thoroughly.

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

Disodium Cocoamphodiacetate

Lauryl Glucoside

Sodium Lauroyl Glutamate

Glycerin

Pentylene Glycol

Citric Acid

Sorbitan Caprylate

Panthenol

Propanediol

Trehalose

Water(Aqua)

Centella Asiatica Extract

Dipotassium Glycyrrhizate

Dimethyl Sulfone

Portulaca Oleracea Extract

Hizikia Fusiforme Extract

Glycyrrhiza Glabra (Licorice) Root Extract

Houttuynia Cordata Extract

Coptis Japonica Root Extract

Yeast Beta-Glucan

Betaine

Hyaluronic Acid

Aloe Barbadensis Leaf Extract

Levulinic Acid

Olea Europaea (Olive) Fruit Oil

Camellia Sinensis Leaf Extract

Opuntia Ficus-Indica Fruit Extract

Polygonum Cuspidatum Root Extract

Scutellaria Baicalensis Root Extract

Camellia Japonica Seed Oil

Rosmarinus Officinalis (Rosemary) Leaf Extract

Tocopherol

Bioflavonoids

Chamomilla Recutita (Matricaria) Leaf Extract

Bisabolol

Rosa Canina Fruit Oil

Brassica Oleracea Italica (Broccoli) Extract

Michelia Alba Flower Oil

Rose Flower Oil

Cananga Odorata Flower Oil

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

protect the skin from dryness and irritation while leaving baby's skin clean and fresh

Section 55106-9 (55106-9)

glycerin


Advanced Ingredient Data


Raw Label Data

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