SIGNATURE CARE 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:
Safeway
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anti-itch
Authorization status:
OTC monograph not final
Authorization number:
21130-395-16, 21130-395-64

SIGNATURE CARE HYDROCORTISONE- hydrocortisone cream

Safeway

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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Better Living Brands LLC Hydrocortisone 1% Cream Drug Facts

Active ingredient

Hydrocortisone 1%

Purpos e

Anti-itch

Us es

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

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 only be under the advice and supervision of a doctor

in the genital area if you have a vaginal discharge. Consult a doctor.

for the treatment of diaper rash. Consult a doctor.

avoid contact with the 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

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Other information

Inactive ingredients

water, cetearyl alcohol, ceteareth-20, cetyl palmitate, glycerin, isopropyl myristate, isostearyl

neopentanoate, methylparaben, aloe barbadensis leaf juice

Questions or comments?

1-800-719-9260

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Compare to Cortizone -10

active ingredient

Quality Guaranteed

Hydrocortisone 1% Cream

Anti-Itch Cream WITH SOOTHING ALOE

#1 DOCTOR RECOMMENDED ANTI-ITCH ACTIVE INGREDIENT

MAXIMUM STRENGTH

LASTS 10 HOURS

Skin irritation & rashes

Insect bites – Poison ivy

Eczema & psoriasis

Inflammation & redness

Absorbs quickly

With soothing aloe

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

rectal bleeding occurs

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: do not use, Consult 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: Consult a doctor

store at 20-25°C (68-77°F)

NET WT 2 OZ (56 g)

SIGNATURE CARE HYDROCORTISONE

hydrocortisone cream

Product Information

Safe way

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:21130 -39 5

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)

PO LYO XYL 2 0 CETO STEARYL ETHER (UNII: YRC528 SWUY)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

CETYL PALMITATE (UNII: 5ZA2S6 B0 8 X)

GLYCERIN (UNII: PDC6 A3C0 OX)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

WATER (UNII: 0 59 QF0 KO0 R)

ISO STEARYL NEO PENTANO ATE (UNII: 411THY156 Q)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:21130 -39 5-16

1 in 1 CARTON

10 /24/20 15

1

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

2

NDC:21130 -39 5-6 4

1 in 1 CARTON

0 1/30 /20 18

2

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

10 /24/20 15

Labeler -

Safeway (009137209)

Revised: 10/2019

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