BALMEX DIAPER RASH- zinc oxide cream 
Randob Labs,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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Balmex® Diaper Rash

Drug Facts

Active ingredients Purpose
Zinc Oxide 11.3%Skin protectant

Uses

Warnings

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 again within a few days.

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

Directions

Other information

Inactive ingredients Beeswax, benzoic acid, dimethicone, fragrance, glycine soja (soybean) oil, magnesium aspartate, methylparaben, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europea (olive) leaf extract, panthenol, potassium aspartate, potassium hydroxide, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)

Questions?

1-833-389-9450

Dist. by: RANDOB LABS LTD. Box 440, Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

NEW LOOK-SAME PRODUCT

Balmex®
COMPLETE
PROTECTION™

Zinc Oxide

DIAPER RASH CREAM

Prevents & Heals

Protects against
all 3 leading causes
of diaper rash
Reduces rash in
just 1 diaper change

Pediatrician Recommended

Advanced
Formula

NET WT 4 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
BALMEX DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.113 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Yellow Wax (UNII: 2ZA36H0S2V)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Dimethicone 100 (UNII: RO266O364U)  
Soybean Oil (UNII: 241ATL177A)  
Magnesium Aspartate Anhydrous (UNII: 082H981FMA)  
Methylparaben (UNII: A2I8C7HI9T)  
Microcrystalline Wax (UNII: XOF597Q3KY)  
Mineral Oil (UNII: T5L8T28FGP)  
Oenothera Biennis (UNII: 76UI55V071)  
Olea Europaea Leaf (UNII: MJ95C3OH47)  
Dexpanthenol (UNII: 1O6C93RI7Z)  
Potassium Aspartate (UNII: OC4598NZEQ)  
Potassium Hydroxide (UNII: WZH3C48M4T)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
Sarcosine (UNII: Z711V88R5F)  
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
Tocopherol (UNII: R0ZB2556P8)  
Water (UNII: 059QF0KO0R)  
Sodium Cocoyl Glycinate (UNII: XLU9KH03XM)  
White Wax (UNII: 7G1J5DA97F)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52412-400-041 in 1 CARTON11/01/2018
1113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:52412-400-16453 g in 1 JAR; Type 0: Not a Combination Product11/01/2018
3NDC:52412-400-021 in 1 CARTON11/01/2018
356 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:52412-400-055.1 g in 1 PACKAGE; Type 0: Not a Combination Product11/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34704/27/2015
Labeler - Randob Labs,Ltd. (061995007)
Establishment
NameAddressID/FEIBusiness Operations
KIK HOLDCO COMPANY INC.243547333MANUFACTURE(52412-400)

Revised: 11/2018
Document Id: 18af2fdd-d234-4675-afc6-e0bdd19cdbbd
Set id: f202dd0e-7c61-4ea1-a5f6-e90898366ba3
Version: 1
Effective Time: 20181113
 
Randob Labs,Ltd.