HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH- hydrocortisone cream

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

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Active ingredient:
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Available from:
NuCare Pharmaceuticals, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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            •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:
68071-3197-1

HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH- hydrocortisone cream

NuCare Pharmaceuticals, Inc.

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 MAXIMUM STRENGTH

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 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

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 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?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PRINCIPAL DISPLAY PANEL

HYDROCORTISONE WITH ALOE MAXIMUM STRENGTH

hydrocortisone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 71-319 7(NDC:0 472-0 339 )

NuCare Pharmaceuticals, Inc.

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)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 71-319 7-1

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

0 6 /14/20 17

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 7/0 8 /19 9 8

Labeler -

NuCare Pharmaceuticals, Inc. (010632300)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NuCare Pharmaceuticals, Inc.

0 10 6 3230 0

re la be l(6 8 0 71-319 7)

Revised: 4/2019

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