BABY DIAPER- zinc oxide cream 
TELLURIAN

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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ACTIVE INGREDIENTS

ZINC OXIDE, 10%

PURPOSE

SKIN PROTECTANT

USE

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT DO NOT GET INTO EYES.

STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER 7 DAYS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, SEEK MEDICAL HELP OR CALL POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

Inactive Ingredients: Water, Ethylhexyl Palmitate, Ricinus Communis (Castor) Seed Oil, Polyglycerin-6 Polyricinoleate, Polyglyceryl-10 Hexaoleate, Glycerin, Dimethicone, Sodium PCA, Ceramide 2, Ceramide 3, Ceramide 6lf, Aloe Barbadensis Leaf Juice, Hyaluronic Acid, Macadamia Ternifolia Seed Oil, Vegetable Oil, Camellia Saliva Seed Oil, Phytostearyl Canola Glycerides, Chamomilla Recutita (Matricaria) Extract, Panthenol (Vitamin B5), Tocopheryl Linoleate, Hydrogenated Coco-Glycerides, Myristyl Myristate, Sorbitan Laurate, Sodium Chloride, Zinc Sulfate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Sodium Benzoate, Potassium Sorbate.

image description

BABY DIAPER 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42643-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 g  in 10 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CASTOR OIL (UNII: D5340Y2I9G)  
POLYGLYCERIN-6 (UNII: M51422LRAM)  
POLYGLYCERYL-10 HEXAOLEATE (UNII: 8S25IPV09I)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
CERAMIDE 3 (UNII: 4370DF050B)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
CERAMIDE 2 (UNII: C04977SRJ5)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYALURONIC ACID (UNII: S270N0TRQY)  
MACADAMIA OIL (UNII: 515610SU8C)  
CORN OIL (UNII: 8470G57WFM)  
CANOLA OIL (UNII: 331KBJ17RK)  
MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Coco-Glycerides (UNII: ISE9I7DNUG)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ZINC SULFATE ANHYDROUS (UNII: 0J6Z13X3WO)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42643-101-14100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2013
Labeler - TELLURIAN (054233646)

Revised: 11/2014
Document Id: 455881bc-4c62-4439-b7dc-ce2a80bb9142
Set id: a2a41914-c98b-4b35-9d12-6fb0041c7e1d
Version: 6
Effective Time: 20141115
 
TELLURIAN