BALMEX DIAPER RASH- zinc oxide 11.3% 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 Cream

Zinc Oxide 11.3%

Skin Protectant

Helps treat and prevent diaper rash, protects chafed skin due to diaper rash and helps seal out wetness.

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.

If swallowed, seek medical help or contact a Poison Control Center immediately.

Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Beeswax, benzoic acid, dimethicone, glycine soja (soybean) oil, magnesium aspartate, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europae (olive) leaf extract, panthenol, Peruvian balsam, Phenoxyethanol, potassium aspartate, potassium hydroxide, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water.

Label

BALMEX DIAPER RASH 
zinc oxide 11.3% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-285
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
SOYBEAN OIL (UNII: 241ATL177A)  
MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MINERAL OIL (UNII: T5L8T28FGP)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
PANTHENOL (UNII: WV9CM0O67Z)  
BALSAM PERU (UNII: 8P5F881OCY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM ASPARTATE (UNII: OC4598NZEQ)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SARCOSINE (UNII: Z711V88R5F)  
COCO ACID CHLORIDES (UNII: R7N8Y0XMX7)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52412-285-16453 g in 1 JAR; Type 0: Not a Combination Product04/19/2021
2NDC:52412-285-12340 g in 1 JAR; Type 0: Not a Combination Product04/19/2021
3NDC:52412-285-041 in 1 CARTON04/19/2021
3113 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:52412-285-021 in 1 CARTON04/19/2021
456 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:52412-285-031 in 1 CARTON04/04/2023
585 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01604/19/2021
Labeler - Randob Labs, LTD (061995007)
Registrant - Derma Care Research Labs (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs116817470manufacture(52412-285)

Revised: 4/2023
Document Id: f886f501-1199-1e7e-e053-6394a90a20b8
Set id: f7f7a89d-d4e0-9faa-e053-6294a90aaf7b
Version: 2
Effective Time: 20230404
 
Randob Labs, LTD