DR. OBERON NATURAL BABY- allantoin lotion 
Oberon Cosmetic Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DR. OBERON NATURAL BABY LOTION

Allantoin (26%

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

image description

DR. OBERON NATURAL BABY 
allantoin lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52891-103
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (ALLANTOIN) ALLANTOIN0.5   in 50 mL
Inactive Ingredients
Ingredient NameStrength
water 
Glycerin 
CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE 
CETEARYL OLIVATE 
SORBITAN OLIVATE 
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER 
Trehalose 
Betaine 
PHENYL TRIMETHICONE 
Squalane 
ZANTHOXYLUM PIPERITUM FRUIT PULP 
PULSATILLA KOREANA WHOLE 
USNEA BARBATA 
CARBOMER 1342 
Arginine 
CAPRYLYL GLYCOL 
Panthenol 
CERAMIDE 3 
GLYCYRRHIZA GLABRA 
CAMELLIA SINENSIS FLOWER 
ROSMARINUS OFFICINALIS FLOWER 
CENTELLA ASIATICA 
MATRICARIA CHAMOMILLA FLOWERING TOP OIL 
SCUTELLARIA BAICALENSIS ROOT 
POLYGONUM CUSPIDATUM ROOT 
BUTYLENE GLYCOL 
PUNICA GRANATUM WHOLE 
P-anisic acid 
DIPOTASSIUM GLUCOSE-6-PHOSPHATE 
XANTHAN GUM 
LAVANDULA ANGUSTIFOLIA WHOLE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52891-103-021 in 1 CARTON
1NDC:52891-103-0150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/21/2014
Labeler - Oberon Cosmetic Co., Ltd. (631155194)
Registrant - Oberon Cosmetic Co., Ltd. (631155194)
Establishment
NameAddressID/FEIBusiness Operations
Oberon Cosmetic Co., Ltd.631155194manufacture(52891-103)

Revised: 6/2014
Document Id: eda7b08d-bba5-4672-b0e5-d4c065ef336b
Set id: ee500ff7-132a-47c5-9e5a-2f205af85661
Version: 1
Effective Time: 20140619
 
Oberon Cosmetic Co., Ltd.