CELESTONE-G- betamethasone valerate, gentamicin sulfate ointment 
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, Gentamicin Sulfate

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 the affected area no more than 3 to 4 times daily

Warnings

For external use only.

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 with 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 topical use only

1

CELESTONE-G 
betamethasone valerate, gentamicin sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M) BETAMETHASONE0.61 mg  in 1 g
GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG) GENTAMICIN1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72689-0004-115 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(72689-0004)

Revised: 11/2018
Document Id: 7b220379-77fc-3f7e-e053-2991aa0a78bc
Set id: 7b0fc342-3d3d-b232-e053-2a91aa0a3021
Version: 2
Effective Time: 20181120
 
OASIS TRADING