QUATRIDERM ANTI-ITCH- hydrocortisone cream

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

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Active ingredient:
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Available from:
OPMX LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema seborrheic dermatitis psoriasis insect bites poison ivy, poison oak, and poison sumac cosmetics jewelry detergents soaps temporarily relieves external anal and genital itching other uses of this product should be only under the advice and supervision of a doctor Anti-Itch
Authorization status:
OTC monograph not final
Authorization number:
69729-269-53

QUATRIDERM ANTI-ITCH- hydrocortisone cream

OPMX LLC

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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Quatriderm Hydrocortisone 2 oz

Active Ingredient

Hydrocortisone 1 %

Us es

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

eczema

seborrheic dermatitis

psoriasis

insect bites

poison ivy, poison oak, and poison sumac

cosmetics

jewelry

detergents

soaps

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

When using this product

do not get into the eyes

for external anal itching, do not use more than directed unless told to do so by a doctor

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

Do not use

for the treatment of diaper rash. Ask a doctor.

for external genital itching if you have a vaginal discharge. Ask a doctor.

for external anal itching if rectal bleeding occurs. Consult a doctor promptly.

Stop us and ask doctor if

condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few

days. Do not begin use of any other hydrocortisone product.

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 and over: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

for external anal itching in adults:

when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, or by

patting or blotting with an appropriate cleansing pad.

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

for external anal itching in children under 12 years: ask a doctor

Other information

store at 20 °C to 25 °C (68 °F to 77 °F)

Inactive ingredient

aloe barbadensis (aloe vera) leaf juice, cetearyl alcohol, glycerin, methylparaben, mineral oil,

propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, white petrolatum, white

Purpos e

Anti-Itch

Content of labeling

Hydrocortisone Cream 1% with Aloe Vera

QUATRIDERM ANTI-ITCH

hydrocortisone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 729 -26 9

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

PETRO LATUM (UNII: 4T6 H12BN9 U)

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

GLYCERIN (UNII: PDC6 A3C0 OX)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

OPMX LLC

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

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

LIGHT MINERAL O IL (UNII: N6 K578 7QVP)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

WATER (UNII: 0 59 QF0 KO0 R)

WHITE WAX (UNII: 7G1J5DA9 7F)

SO DIUM CETO STEARYL SULFATE (UNII: 7ZBS0 6 BH4B)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 729 -26 9 -53

1 in 1 CARTON

0 2/10 /20 19

1

56 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 2/10 /20 13

Labeler -

OPMX LLC (029918743)

Registrant -

Weeks & Leo (005290028)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Weeks & Leo Co ., Inc.

0 0 529 0 0 28

ma nufa c ture (6 9 729 -26 9 )

Revised: 3/2019

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