Label: AFASSCO 1% HYDROCORTISONE- hydrocortisone ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 51532-4608-1, 51532-4608-2 - Packager: Afassco Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 12, 2023
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTIONDrug Facts - Hydrocorticone Cream 1%
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ACTIVE INGREDIENTActive Ingredients (In Each Gram) Hydrocortisone 1%
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PURPOSEPurpose Anti-itch
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INDICATIONS & USAGEUses: for the temporary temporarily relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps ...
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WARNINGSWarnings - for external use only
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ASK DOCTORConsult a doctor: before use if you have a vaginal discharge (for external feminine itching) for external itching, do not exceed the recommended daily dosage or if bleeding occurs - if condition ...
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WHEN USINGWhen using this product: avoid contacty with eyes - do not put this produce into rectum by using fingers or any mechanical device or applicator
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DO NOT USEDo not use: with any other Hydrocortisone product unless you have consulted a doctor
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KEEP OUT OF REACH OF CHILDRENKEEP OUT OF REACH OF CHILDREN. If swallowed contact a Poison Control center right away.
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DOSAGE & ADMINISTRATIONDirections - • For adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily - • Children under 2 years of age; do not use, consult a doctor - • Adults for ...
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OTHER SAFETY INFORMATIONOther Information: Store at controlled room temperature 15° to 30° C (59° to 86° F) Tamper evident. Do not use if packet is torn, cut, or opened. Avoid excessive heat and humidity
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INACTIVE INGREDIENTInactive Ingredients - Water, Cetearyl Alcohol, Glycerin, Ceteareth-20, Isopropyl Myristate, EDTA-2NA, Phenoxyethanol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice
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Principal Display Panel
Afassco¦ ¦® The First Choice - in First Aid - MAXIMUM STRENGTH - HYDROCORTISONE - PLUS MOISTURIZING ALOE - 1% ANTI-ITCH ANALGESIC • FOR THE - TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS - No ...
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INGREDIENTS AND APPEARANCEProduct Information