GERLASAN HAND- clotrimazole cream 
Eduard Gerlach oHG

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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Active Ingredients

Urea 5%

Clotrimazole 0.6%

Purpose

Binds moisture. Help to prevent the growth of pathogens

Uses

  • Provides protection for the skin on the hands.
  • Dry skin becomes smooth and soft

Warning

For external use only.

When using this product

avoid contact with eyes

Stop use and ask a Doctor if

keep out or reach of children.

If swallowed get medical help or contact a poison control center right away

Directions

Apply regularly to protect the hands from dry out, from cracked skin and cross contamination of germs such as banteria and fungi

Other Information

Store at 20-25° C (68°-77° F)

Inactive Ingredients

Aqua (Water), Urea, Paraffinum Liquidum (Mineral Oil), Polyglyceryl-3 Methylglucose Distearate, Isopropyl Palmitate, Octyldodecanol, Glyceryl Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Cetyl Alcohol, Glycerin, Dimethicone, Tapioca Starch, Panthenol, Aloe Barbadensis Leaf Juice Powder, Bisabolol, Triethyl Citrate, Xanthan Gum, Parfum (Fragrance), Methylparaben, Ethylparaben, Phenoxyethanol, Caprylyl Glycol, Clotrimazol,

Benzyl Salicylate, Citronellol, Hexyl Cinnamal, Butylphenyl Methylpropional, Limonene, Linalool, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Alpha-Isomethyl Ionone

Gerlasan Hand Cream

image description

GERLASAN HAND 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45264-004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (Clotrimazole) Clotrimazole0.45 mL  in 75 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
MINERAL OIL 
UREA 
POLYGLYCERYL-3 DIISOSTEARATE 
ISOPROPYL PALMITATE 
OCTYLDODECANOL 
GLYCERYL MONOSTEARATE 
GLYCERIN 
CETYL ALCOHOL 
JOJOBA OIL 
DIMETHICONE 
STARCH, TAPIOCA 
PANTHENOL 
PHENOXYETHANOL 
TRIETHYL CITRATE 
XANTHAN GUM 
LEVOMENOL 
METHYLPARABEN 
ETHYLPARABEN 
CAPRYLYL GLYCOL 
METHYLPROPANEDIOL 
CAPRYLHYDROXAMIC ACID 
ETHYLHEXYLGLYCERIN 
ALOE VERA LEAF 
Packaging
#Item CodePackage Description
1NDC:45264-004-281 in 1 BOX
1NDC:45264-004-2775 mL in 1 TUBE
2NDC:45264-004-29500 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/04/2008
Labeler - Eduard Gerlach oHG (551402480)
Registrant - Eduard Gerlach oHG (551402480)
Establishment
NameAddressID/FEIBusiness Operations
Eduard Gerlach oHG551402480manufacture

Revised: 06/2012
 
Eduard Gerlach oHG