BALMEX ADULT CARE 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® ADULT CARE RASH

Drug Facts

Active Ingredients                                     Purpose
Zinc Oxide 11.3%Skin protectant

Uses

Warnings

For external use only

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist 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

Inactive ingredients mineral oil, water, beeswax, microcrystalline wax, synthetic beeswax, fragrance, sorbitan sesquioleate, oenothera biennis (evening primrose) seed extract, olea europaea (olive) leaf extract, dimethicone, tocopherol, methylparaben, glycine soja (soybean) oil, propylparaben, panthenol, sarcosine, benzoic acid, potassium aspartate, potassium hydroxide, magnesium aspartate, sodium cocoyl amino acids (309-021) 

For more information please visit 
www.BalmexAdult.com

Distributed by RANDOB LABS LTD.
Box 440, Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

Activ
Guard™

NEUTRALIZES
IRRITANTS

Balmex®
ADULTCARE

RASH CREAM
ZINC OXIDE 11.3%

Soothes &
Protects Skin
From Irritation, Chafing & Rash

Dermatologist Tested
Works in One Use*
Odor-Free

NET WT 3 OZ (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
BALMEX ADULT CARE RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-500
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
Mineral Oil (UNII: T5L8T28FGP)  
Water (UNII: 059QF0KO0R)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Microcrystalline Wax (UNII: XOF597Q3KY)  
Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
Oenothera Biennis (UNII: 76UI55V071)  
Olea Europaea Leaf (UNII: MJ95C3OH47)  
Dimethicone 100 (UNII: RO266O364U)  
Tocopherol (UNII: R0ZB2556P8)  
Methylparaben (UNII: A2I8C7HI9T)  
Soybean Oil (UNII: 241ATL177A)  
Propylparaben (UNII: Z8IX2SC1OH)  
Dexpanthenol (UNII: 1O6C93RI7Z)  
Sarcosine (UNII: Z711V88R5F)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Potassium Aspartate (UNII: OC4598NZEQ)  
Potassium Hydroxide (UNII: WZH3C48M4T)  
Magnesium Aspartate Anhydrous (UNII: 082H981FMA)  
Sodium Cocoyl Glycinate (UNII: XLU9KH03XM)  
Propylene Glycol (UNII: 6DC9Q167V3)  
White Wax (UNII: 7G1J5DA97F)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52412-500-031 in 1 CARTON11/01/2018
185 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:52412-500-12340 g in 1 JAR; 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(52412-500)

Revised: 11/2018
Document Id: 3b905d74-d3d4-4b83-8c32-3a3ead9d23cc
Set id: 9443a987-c7b2-4b0d-a9dc-02233135af81
Version: 1
Effective Time: 20181113
 
Randob Labs,Ltd.