SUDOCREM SKIN PROTECTANT CREAM

SUDOCREM SKIN PROTECTANT by

Drug Labeling and Warnings

SUDOCREM SKIN PROTECTANT by is a Otc medication manufactured, distributed, or labeled by LEDA INNOVATIONS USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUDOCREM SKIN PROTECTANT- zinc oxide cream 
LEDA INNOVATIONS USA, INC.

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SUDOCREM SKIN PROTECTANT CREAM

Drug Facts

Active ingredient

Zinc Oxide (15%)

Purpose

Skin protectant

Uses

  • Helps treat and prevent Diaper Rash and Incontinence Dermatitis
  • Protects chafed skin and minor skin irritations due to diaper rash and helps protect from wetness

Warnings

For external use only.

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • conditions 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 right away

Directions

  • Apply as needed
  • For diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow it 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.

Other information

  • Store at room temperature between 15C and 30C (59F to 86F)
  • Do not use if safety seal is broken or missing

Inactive ingredients

paraffin, paraffin wax, lanolin, microcrystalline wax, sorbitan sesquioleate, benzyl benzoate, beeswax, sodium benzoate, benzyl alcohol, propylene glycol, benzyl cinnamate, lavender oil, linalyl acetate, butylated hydroxyanisole, citric acid.

Product Packaging

1

SUDOCREM SKIN PROTECTANT 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 84589-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
LINALYL ACETATE (UNII: 5K47SSQ51G)  
BENZYL CINNAMATE (UNII: V67O3RO97U)  
BENZYL BENZOATE (UNII: N863NB338G)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 84589-001-101 in 1 BLISTER PACK08/06/2024
110 g in 1 JAR; Type 0: Not a Combination Product
2NDC: 84589-001-6060 g in 1 JAR; Type 0: Not a Combination Product08/06/2024
3NDC: 84589-001-12125 g in 1 JAR; Type 0: Not a Combination Product08/06/2024
4NDC: 84589-001-25250 g in 1 JAR; Type 0: Not a Combination Product08/06/2024
5NDC: 84589-001-40400 g in 1 JAR; Type 0: Not a Combination Product08/06/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01608/06/202408/06/2024
Labeler - LEDA INNOVATIONS USA, INC. (779937036)

Revised: 8/2024
Document Id: 20d31212-4426-85c4-e063-6394a90a19ff
Set id: 1f0a67cb-cbd1-2314-e063-6394a90a09e4
Version: 2
Effective Time: 20240829