Hydrocortisone by AKRON PHARMA INC / SLV PHARMACEUTICALS LLC HYDROCORTISONE lotion

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by AKRON PHARMA INC, SLV PHARMACEUTICALS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone 1% (Micronized)

Purpose

Antipruritic (Anti-itch)

Use

For the temporary relief of minor skin irritations, inflammations, itching and rashes caused by:

• insect bites
• eczema
• psoriasis
• soaps
• detergents
• cosmetics,
• jewelry,
• poison oak,
• poison sumac
• Other uses of this product should be undertaken only under the advice and supervision of a doctor.

Warnings

For external use only.

When using this product

Do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

• Condition worsens
• If symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
• Do no use for diaper rash. Consult a doctor.

Keep out of Reach of Children

Keep out of the reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

• Shake will before using.
• For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily.
• For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a doctor.

Other Information

Store away from excessive heat or cold. Shake well before using.

Inactive Ingredients

Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Lauryl Sulfate, Stearyl Alcohol, Aloevera, Xanthan Gum

Questions?

Please Call 1(877) 225-6999

SPL UNCLASSIFIED SECTION

Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ 07004

Rev. 03/19

Manufactured in U.S.A

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71399-0120
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 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71399-0120-1	1 in 1 CARTON	03/21/2019
1		120 mL in 1 BOTTLE; 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	03/21/2019

Labeler - AKRON PHARMA INC (067878881)

Establishment
Name	Address	ID/FEI	Business Operations
SLV PHARMACEUTICALS LLC		081225162	manufacture(71399-0120)