HYDROCORTISONE- hydrocortisone cream

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

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Active ingredient:
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Available from:
Valu Merchandisers, Co.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-itch temporarily relieves itching associated with minor skin irritation, 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 only be under the advice and supervision of a doctor
Authorization status:
OTC monograph not final
Authorization number:
63941-229-01

HYDROCORTISONE- hydrocortisone cream

Valu Merchandisers, Co.

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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Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpos e

Anti-itch

Us es

temporarily relieves itching associated with minor skin irritation, 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 only be 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

store at room temperature

Inactive ingredient

aloe barbadensis, butylated hydroxytoluene, carbomer 940, cetyl alcohol, ethylparaben, glycerin,

glycerin monosterate, propylene glycol, purified water, stearic acid sodium lauryl sulfate,

trethanolamine

Package label

Best Choice Hydrocortisone with Aloe

HYDROCORTISONE

hydrocortisone cream

Product Information

Valu Merchandisers, Co.

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 39 41-229

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

10 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

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

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

CARBO MER 9 4 0 (UNII: 4Q9 3RCW27E)

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

GLYCERIN (UNII: PDC6 A3C0 OX)

ETHYLPARABEN (UNII: 14255EXE39 )

GLYCERYL 1-STEARATE (UNII: 258 49 1E1RZ)

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

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 39 41-229 -0 1

1 in 1 BOX

0 1/30 /20 17

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 mo no graph no t final

pa rt348

0 1/30 /20 12

Labeler -

Valu Merchandisers, Co. (868703513)

Revised: 4/2019

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