HYDROCORTISONE WITH ALOE- hydrocortisone cream

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

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Active ingredient:
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)
Available from:
TARGET Corporation
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-itch - temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis - eczema - psoriasis - poison ivy, oak, sumac - insect bites - detergents - jewelry - cosmetics - soaps - seborrheic dermatitis - temporarily relieves external anal and genital itching - other uses of this product should be only under the advice and supervision of a doctor
Authorization status:
OTC monograph not final
Authorization number:
11673-392-02

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HYDROCORTISONE WITH ALOE- hydrocortisone cream

TARGET Corporation

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.

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Hydrocortisone

with Aloe

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpos e

Anti-itch

Us es

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

eczema

psoriasis

poison ivy, oak, sumac

insect bites

detergents

jewelry

cosmetics

soaps

seborrheic dermatitis

temporarily relieves external anal and genital 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

in the genital area 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 eyes

do not use more than directed unless told to do so by a doctor

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

Stop use and ask a doctor if

condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few

days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

rectal bleeding occurs

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

away.

Directions

for itching of skin irritation, inflammation, and rashes:

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: ask a doctor

for external anal and genital itching, adults:

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

gently dry by patting or blotting with toilet tissue or a soft cloth before applying

apply to affected area not more than 3 to 4 times daily

children under 12 years of age: ask a doctor

Other information

To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube

store at room temperature

see carton or tube crimp for lot number and expiration date

Inactive ingredients

aloe powder, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, citric acid, glycerin,

glyceryl monostearate, methylparaben, mineral oil, paraffin wax, propylparaben, purified water, sodium

lauryl sulfate, stearyl alcohol

Ques tions ?

Call 1-800-910-6874

Distributed by Target Corporation

Minneapolis, MN 55403

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

up&up

maximum strength

hydrocortisone cream 1% with aloe

anti-itch

NET WT 1 OZ (28.4 g)

HYDROCORTISONE WITH ALOE

hydrocortisone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:116 73-39 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Hydro co rtiso ne (UNII: WI4X0 X7BPJ) (Hydro co rtiso ne - UNII:WI4X0 X7BPJ)

Hydro c o rtiso ne

1 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

ceto stea ryl a lco ho l (UNII: 2DMT128 M1S)

so dium la uryl sulfa te (UNII: 36 8 GB5141J)

so dium ceto stea ryl sulfa te (UNII: 7ZBS0 6 BH4B)

citric a cid mo no hydra te (UNII: 29 6 8 PHW8 QP)

g lycerin (UNII: PDC6 A3C0 OX)

g lyceryl mo no stea ra te (UNII: 230 OU9 XXE4)

methylpa ra ben (UNII: A2I8 C7HI9 T)

minera l o il (UNII: T5L8 T28 FGP)

TARGET Corporation

pa ra ffin (UNII: I9 O0 E3H2ZE)

pro pylpa ra ben (UNII: Z8 IX2SC1OH)

wa ter (UNII: 0 59 QF0 KO0 R)

stea ryl a lco ho l (UNII: 2KR8 9 I4H1Y)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:116 73-39 2-0 2

1 in 1 CARTON

10 /19 /20 20

1

28 .4 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

10 /19 /20 20

Labeler -

T ARGET Corporation (006961700)

Revised: 12/2020

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