DERMOCREM- zinc oxide cream 
INTERNATIONAL ETHICAL LABS, INC

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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Drug Facts

Drug Facts

Active ingredient

Zinc oxide 15.25%

Purpose

Skin protectant

Uses

helps treat and prevent diaper rash

protects chafed skin due to diaper rash and helps seal out wetness

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 right away.

Directions

change wet or soiled diapers promptly

cleanse the diaper area

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.

Other information

store at controlled room temperature 15° to 30°C (59° to 89°F).

in a safety seal jar. Do not use if seal is broken.

Inactive ingredients

besewax, benzyl alcohol, benzyl benzoate, benzyl cinnamate, butylated hydroxyanisole, citric acid, lanolin, lavender fragrance, linalyl acetate, liquid paraffin, microcrystalline wax, paraffin wax, propylene glycol, purified water, sodium benzoate, sorbitan sesquioleate.

Questions

1-800-981-5068

Principal Display Panel

NDC 11025-118-14

Dermocrem
(Zinc Oxide Cream)
Skin Protectant

For the Treatment & Prevention
of Diaper Rash

Net wt 8.8 oz (250 g)

Image

DERMOCREM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11025-118
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE152.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BENZYL CINNAMATE (UNII: V67O3RO97U)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
LINALYL ACETATE (UNII: 5K47SSQ51G)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BENZYL BENZOATE (UNII: N863NB338G)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11025-118-13125 g in 1 JAR; Type 0: Not a Combination Product05/30/200603/12/2023
2NDC:11025-118-14250 g in 1 JAR; Type 0: Not a Combination Product06/08/201603/08/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/30/200603/12/2023
Labeler - INTERNATIONAL ETHICAL LABS, INC (091176933)

Revised: 1/2021
 
INTERNATIONAL ETHICAL LABS, INC