AFASSCO 1% HYDROCORTISONE- hydrocortisone ointment

AFASSCO 1% Hydrocortisone by

Drug Labeling and Warnings

AFASSCO 1% Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Afassco Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Hydrocorticone Cream 1%

ACTIVE INGREDIENT

Active Ingredients (In Each Gram)

Hydrocortisone 1%

PURPOSE

Purpose 

Anti-itch

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

Warnings

• for external use only

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

When using this product:

• avoid contacty with eyes
• do not put this produce into rectum by using fingers or any mechanical device or applicator

DO NOT USE

Do not use:

• with any other Hydrocortisone product unless you have consulted a doctor

KEEP OUT OF REACH OF CHILDREN

• KEEP OUT OF REACH OF CHILDREN.  If swallowed contact a Poison Control center right away.

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

Other 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

INACTIVE INGREDIENT

Inactive Ingredients

Water, Cetearyl Alcohol, Glycerin,

Ceteareth-20, Isopropyl Myristate,

EDTA-2NA, Phenoxyethanol,

Tocopheryl Acetate,

Aloe Barbadensis Leaf Juice

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. 608                                25 ct.

Afassco¦ ¦®

The First Choice in First Aid

REMOVE TOP FOR EASY ACCESS

Compare To

Hydrocortisone

MAXIMUM STRENGTH
HYDROCORTISONE

1% ANTI-ITCH ANALGESIC FOR THE

TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS

No. 608                    25 ct.

Afassco¦ ¦®

The First Choice in First Aid

MAXIMUM STRENGTH
HYDROCORTISONE

1% 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

INGREDIENTS AND APPEARANCE

AFASSCO 1% HYDROCORTISONE 
hydrocortisone ointment

Product 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)