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
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
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INDICATIONS & USAGE
Uses:
- 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, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis scrapes
- for external genital, feminine, and anal itching
- other uses of this product should be only under the advice and supervision of a doctor
- WARNINGS
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ASK DOCTOR
Consult 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 worsens or if symptoms persist for more than 7 days or clear up and occur again in a few days
- ask a doctor before use if you are using any other hydrocortisone product
- WHEN USING
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
• 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 external anal itching when practical, cleanse the area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
• Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product
• Children under 12 years of age; for external itching, consult a doctor - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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Principal Display Panel
Afassco¦ ¦®
The First Choice
in First AidMAXIMUM STRENGTH
HYDROCORTISONE
PLUS MOISTURIZING ALOE1% ANTI-ITCH ANALGESIC • FOR THE
TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS
No. 608 25 ct.
Afassco¦ ¦®
The First Choice in First Aid
REMOVE TOP FOR EASY ACCESS
Compare To
Hydrocortisone
MAXIMUM STRENGTH
HYDROCORTISONE1% ANTI-ITCH ANALGESIC • FOR THE
TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS
No. 608 25 ct.
Afassco¦ ¦®
The First Choice in First Aid
MAXIMUM STRENGTH
HYDROCORTISONE1% Crema de Fydrocortisona
instructiones: Para Adultos y ninos
2 anos y mas viejo. Los ninos bajo
2 anos, consultan un medico para
picar anal externo. Limpia el areaa
afectada con jabon y aclarado
aplique el producto.
1% ANTI-ITCH ANALGESIC • FOR THE
TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS
No. 608 25 ct.
Afassco¦ ¦®
The First Choice in First Aid
Manufactured for Afassco, Inc. Minden, NV 89423
6 70254 60812 5
↓25 ct. Box↓
↓6 ct. Box↓
↓Unit Dose Package Label↓
Afassco¦ ¦®
The First Choice in First Aid
1% Hydrocortisone
Cream
Manufactured for Afassco
Minden, NV 89423
1gm (1/32 oz)
Made in China
res
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INGREDIENTS AND APPEARANCE
AFASSCO 1% HYDROCORTISONE
hydrocortisone ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51532-4608 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51532-4608-1 25 in 1 BOX 12/07/2018 1 1 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:51532-4608-2 6 in 1 BOX 12/07/2018 2 1 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/07/2018 Labeler - Afassco Inc. (609982723) Registrant - Afassco Inc. (956159800)