AMOLG A- betamethasone valerate, gentamicin sulfate cream 
OASIS TRADING

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Betamethasone Valerate 0.61mg/g
Gentamicin Sulfate 1mg/g

temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, poison ivy, poison oak, or poison sumac soaps detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, external genital and anal itching

Keep out of reach of children

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

Do not use in the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator
Ask a doctor before use if you have a vaginal discharge rectal bleeding
diaper rash
When using this product consult a doctor before exceeding recommended dosage
Stop use and ask a doctor if condition gets worse condition persists for more than 7 days
condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum

For external use only

1

AMOLG A 
betamethasone valerate, gentamicin sulfate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M) BETAMETHASONE VALERATE0.61 mg  in 1 g
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG) GENTAMICIN1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72689-0033-135 g in 1 TUBE; Type 0: Not a Combination Product11/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/15/2018
Labeler - OASIS TRADING (689991468)
Registrant - OASIS TRADING (689991468)
Establishment
NameAddressID/FEIBusiness Operations
OASIS TRADING689991468manufacture(72689-0033)

Revised: 3/2019
Document Id: 841b6a32-ff4b-e580-e053-2a91aa0a99ee
Set id: 841b69a7-9a5e-13b5-e053-2991aa0a9cca
Version: 1
Effective Time: 20190315
 
OASIS TRADING