Hydrocortisone by B8 Sales, Inc. HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by B8 Sales, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation or Rashes

25 Packets

Each Packet Net.Wt.0.9gm

Drug Facts

Active ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

• for the temporary 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, psoriasis and scrapes
• other uses of this product should be only under the advice and supervision of a doctor

Warnings

• For external use only
• Do not use for the treatment of diaper rash
• not for external genital, feminine and anal itching

Ask a doctor before use:

• 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 within a few days

When using this product

• avoid contact with eyes
• do not put this product into rectum or vagina by using fingers or any mechanical device or applicator

Do not use

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

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• for adults and children 2 years of age and older apply
  to affected area 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 affected 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 a soft cloth before application of this product

Other information

• store at room temperature (do not freeze)
• do not use any opened or torn packets

Inactive ingredients

emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

Manufactured for: B8 SALES

Cincinnati,Ohio 45215

Principal Display Panel

1% Hydrocortisone Cream – Carton Label

PIO Put it on®

1% Hydrocortisone Cream™

For Temporary Relief of Itching Associated with Minor Skin Irritations, Inflammation or Rashes

25 Packets

Each Packet Net.Wt.0.9gm

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50607-5802
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
hydrocortisone (UNII: WI4X0X7BPJ) (hydrocortisone - UNII:WI4X0X7BPJ)	hydrocortisone	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Ethanol (UNII: 3K9958V90M)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
paraffin (UNII: I9O0E3H2ZE)
petrolatum (UNII: 4T6H12BN9U)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
white wax (UNII: 7G1J5DA97F)

Product Characteristics
Color	white (white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50607-5802-1	25 in 1 BOX
1		.9 g in 1 POUCH
2	NDC: 50607-5802-2	144 in 1 BOX
2		.9 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/01/2010

Labeler - B8 Sales, Inc. (833208635)