DR. OBERON NATURAL BABY- allantoin lotion

DR. OBERON NATURAL BABY by

Drug Labeling and Warnings

DR. OBERON NATURAL BABY by is a Otc medication manufactured, distributed, or labeled by Oberon Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Allantoin

Skin protectant

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

For soothing baby’s skin or sensitive skin

Warnings For external use only Do not use on Deep or puncture wounds, Animal bites, Serious burns When using this product Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask doctor If your skin is red, inflamed, itchy or irritated. Store at room temperature

Apply a thin layer of cream and massage in circular motion.

Water, Glycerin, Caprylic/capric triglyceride, Cetearyl olivate, Sorbitan olivate, Sodium hyaluronate, TrehaloseBetaine, Phenyl trimethicone Squalane, Zanthoxylum piperitum fruit extract, Pulsatilla koreana extract, Usnea barbata (lichen) extract, Carbomer, Arginine, Caprylyl glycol, Panthenol, Ceramide 3, Glycyrrhiza glabra (licorice) root extract, Camellia sinesis leaf extract, Rosmarinus officinalis (rosemary) leaf extract, Centella asiatica extract, Chamomilla recutita (matricaria) flower extract, Scutellaria baicalensis root extract, Polygonum cuspidatum root extract, Butylene glycol, Punica granatum fruit extract, P-anisic acid, Dipotassium glycyrrhizate, Xanthan gum, Lavandula angustifolia (lavender) oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. OBERON NATURAL BABY 
allantoin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52891-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.5   in 50 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE (UNII: J4BY50FL78)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
Trehalose (UNII: B8WCK70T7I)
Betaine (UNII: 3SCV180C9W)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
Squalane (UNII: GW89575KF9)
ZANTHOXYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251)
PULSATILLA KOREANA WHOLE (UNII: 5R35881OBK)
USNEA BARBATA (UNII: D6DVA9TCAP)
CARBOMER 1342 (UNII: 809Y72KV36)
Arginine (UNII: 94ZLA3W45F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
Panthenol (UNII: WV9CM0O67Z)
CERAMIDE 3 (UNII: 4370DF050B)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E)
P-anisic acid (UNII: 4SB6Y7DMM3)
DIPOTASSIUM GLUCOSE-6-PHOSPHATE (UNII: ZZW95F4360)
XANTHAN GUM (UNII: TTV12P4NEE)
LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52891-103-02	1 in 1 CARTON
1	NDC: 52891-103-01	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/21/2014

Labeler - Oberon Cosmetic Co., Ltd. (631155194)

Registrant - Oberon Cosmetic Co., Ltd. (631155194)

Establishment
Name	Address	ID/FEI	Business Operations
Oberon Cosmetic Co., Ltd.		631155194	manufacture(52891-103)