DR. OBERON DIAPER RASH BABY CREAM- zinc oxide, dimethicone cream 
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 Diaper Rash Baby Cream

For external use only
When using this product
Do not get into eyes
Stop use and ask a doctor if
Condition worsens
Symptoms last more than 7 days or clear up and occur within a few days.

Zinc Oxide (5%)
Dimethicone (1%)

Skin protectant

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

 Helps treat and prevent diaper rash
 Protects chafed skin due to diaper rash
 Helps seal out wetness

1. Change wet or soiled diapers promptly
2. Clean the diaper area
3. Allow to dry
4. Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time prolonged exposure to wet diapers may be prolonged.

Water, Butylene glycol, Olea europaea (olive) fruit oil, Cetearyl olivate, Sorbitan olivate, Glycerin, Caprylic/capic triglyceride, Beeswax, Cetearyl alcohol, Sodium hyaluronate, Butyrospermum parikli (shea) butter, Theobroma cacao (cocoa) seed butter, Trehalose, Limnanthes alba (meadowfoam) seed oil,, Betula platyphylla japonica juice, glyceryl caprylate, glycerin, portulaca oleracea extract, centella asiatica extract, polyconum cuspidatum root extract, scutellaria baicalensis root extract, camellia sinesis leaf extract, glycyrrhiza glabra (licorice) root extract, Chamomilla ecutita (matricaria) flower extract, Rosmarinus officinalis (rosemary) leaf extract, P-anisic acid, Xanthan gum, Lactic acid, Tocopheryl acetate, Punica granatum fruit extract, Allantoin, Panthenol, Dipotassium glycyrrhizate, Fragrance

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DR. OBERON DIAPER RASH BABY CREAM 
zinc oxide, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52891-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.75 g  in 15 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.15 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene glycol (UNII: 3XUS85K0RA)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
Cetearyl olivate (UNII: 58B69Q84JO)  
Sorbitan olivate (UNII: MDL271E3GR)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
SHEA BUTTER (UNII: K49155WL9Y)  
THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
Trehalose (UNII: B8WCK70T7I)  
LIMNANTHES ALBA WHOLE (UNII: DKY81513ER)  
BETULA PLATYPHYLLA VAR. JAPONICA RESIN (UNII: 1B33PG6N4K)  
glyceryl caprylate (UNII: TM2TZD4G4A)  
glycerin (UNII: PDC6A3C0OX)  
PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
XANTHAN GUM (UNII: TTV12P4NEE)  
LACTIC ACID (UNII: 33X04XA5AT)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E)  
Allantoin (UNII: 344S277G0Z)  
Panthenol (UNII: WV9CM0O67Z)  
DIPOTASSIUM GLUCOSE-6-PHOSPHATE (UNII: ZZW95F4360)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52891-104-021 in 1 CARTON
1NDC:52891-104-0115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/26/2014
Labeler - Oberon Cosmetic Co., Ltd. (631155194)
Registrant - Oberon Cosmetic Co., Ltd. (631155194)
Establishment
NameAddressID/FEIBusiness Operations
Oberon Cosmetic Co., Ltd.631155194manufacture(52891-104)

Revised: 6/2014
Document Id: ed5b7c1e-1d1f-4633-870c-c87cf3f53c33
Set id: 8e32f17b-0e1a-4165-a20c-44d99516b235
Version: 1
Effective Time: 20140626
 
Oberon Cosmetic Co., Ltd.