Label: CELESTONE-G- betamethasone valerate, gentamicin sulfate ointment
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated November 20, 2018
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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.
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
betamethasone valerate, gentamicin sulfate ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72689-0004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M) BETAMETHASONE 0.61 mg in 1 g GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG) GENTAMICIN 1 mg in 1 g Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72689-0004-1 15 g in 1 TUBE; Type 0: Not a Combination Product 11/16/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/15/2018 Labeler - OASIS TRADING (689991468) Registrant - OASIS TRADING (689991468) Establishment Name Address ID/FEI Business Operations OASIS TRADING 689991468 manufacture(72689-0004)