HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH- hydrocortisone cream

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Available from:
Major Pharmaceuticals
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-itch 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 - jewelry - detergents - cosmetics - psoriasis - seborrheic dermatitis - for external genital, feminine and anal itching - other uses of this product should be only under the advice and supervision of a doctor - for external feminine itching if you have a vaginal discharge. Consult a doctor. - for the treatment of diaper rash. Consult a doctor. - symptoms last for more than 7 days - the condition gets worse - symptoms clear up and occur again in a few days - rectal bleeding occurs, consult doctor promptly
Authorization status:
OTC monograph not final
Authorization number:
0904-7623-31

HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH- hydrocortisone cream

Major Pharmaceuticals

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.

----------

Hydrocortisone Cream with Aloe Maximum Strength - Major

Drug Facts

Active ingredient

Hydrocortisone, USP 1%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due

eczema

insect bites

poison ivy

poison oak

poison sumac

soaps

jewelry

detergents

cosmetics

psoriasis

seborrheic dermatitis

for external genital, feminine and anal itching

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 external feminine itching if you have a vaginal discharge. Consult a doctor.

for the treatment of diaper rash. Consult a doctor.

When using this product

avoid contact with the eyes

do not begin the use of any other hydrocortisone product unless directed by a doctor

for external anal itching:

do not use more than directed unless directed by a doctor

do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

symptoms last for more than 7 days

the condition gets worse

symptoms clear up and occur again in a few days

rectal bleeding occurs, consult doctor promptly

Keep out of reach of children.

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

Directions

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

For external anal itching

Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently

dry by patting or blotting with toilet tissue or a soft cloth before application of this product

Children under 12 years of age: consult a doctor

Other information

Store at room temperature 59°-86°F (15°-30°C). Protect from freezing.

Before using any medication, read all label directions. Keep carton, it contains important

information.

Inactive ingredients

aloe vera concentrate, cetyl alcohol, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40

stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sorbic acid, sorbitan

monostearate, stearyl alcohol, white wax. May contain citric acid or sodium citrate solution to adjust

Questions?

1-888-838-2872 between 9 am and 5 pm ET, Monday–Friday.

PRINCIPAL DISPLAY PANEL

Major

NDC 0904-7623-31

Maximum Strength

Hydrocortisone 10

Hydrocortisone Cream, USP 1%

antipruritic (anti-itch) cream With Aloe

Temporary Relief of Itching and Rashes Due To:

Insect Bites Eczema Soaps

Poison Ivy, Oak, Sumac Seborrheic Dermatitis Cosmetics

Psoriasis Jewelry Detergents

Compare to the Active Ingredient in Cortizone 10

NET WT 1 OZ (28 g)

HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH

Major Pharmaceuticals

hydrocortisone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 9 0 4-76 23

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO CO RTISO NE (UNII: WI4X0 X7BPJ) (HYDROCORTISONE - UNII:WI4X0 X7BPJ)

HYDROCORTISONE

1 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PO LYO XYL 4 0 STEARATE (UNII: 13A4J4NH9 I)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

SO RBITAN MO NO STEARATE (UNII: NVZ4I0 H58 X)

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

WHITE WAX (UNII: 7G1J5DA9 7F)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 9 0 4-76 23-31

1 in 1 CARTON

0 4/21/20 0 9

1

28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part348

0 4/21/20 0 9

Labeler -

Major Pharmaceuticals (191427277)

Revised: 11/2019

Similar products

Search alerts related to this product

View documents history

Share this information