DR. OBERON DIAPER RASH BABY CREAM- zinc oxide, dimethicone cream

Dr. Oberon Diaper Rash Baby Cream by

Drug Labeling and Warnings

Dr. Oberon Diaper Rash Baby Cream by is a Otc medication manufactured, distributed, or labeled by Oberon Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

For external use onlyWhen using this productDo not get into eyesStop use and ask a doctor ifCondition worsensSymptoms 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 promptly2. Clean the diaper area3. Allow to dry4. 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. OBERON DIAPER RASH BABY CREAM 
zinc oxide, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52891-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.75 g  in 15 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.15 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52891-104-02	1 in 1 CARTON
1	NDC: 52891-104-01	15 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/26/2014

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(52891-104)