SANDAWHA SOFT BABY WASH- glycerin cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

glycerin

INACTIVE INGREDIENT

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

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

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

WARNINGS

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

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANDAWHA SOFT BABY WASH 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72289-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1.9345 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PANTHENOL (UNII: WV9CM0O67Z)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72289-0004-1	300 g in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	02/24/2019

Labeler - SKINCURE INC (557830240)

Registrant - SKINCURE INC (557830240)

Establishment
Name	Address	ID/FEI	Business Operations
SKINCURE INC		557830240	label(72289-0004) , manufacture(72289-0004)