HYDROCORTISONE 1%- hydrocortisone cream

Hydrocortisone 1% by

Drug Labeling and Warnings

Hydrocortisone 1% by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals Usa Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

temporary relieves external anal itching.

temporary relief of itching associated with minor skin irritations and rashes

other uses of this product should be only under the advice and supervision of a doctor

When Using this Product

Avoid Contact with eyes

do not exceed the recommended daily dosage unless directed by a doctor

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

Warnings

for external use only

Directions

●Adults when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.

●gently dry by patting or blotting with a tissue or soft cloth before application of this product.

●adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.

●children under 12 years of age: do not use, consult a doctor.

Inactive ingredients

Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecanol, petrolatum, purified water, sodium dodecyl sulfate

Other information

● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)

Keep out of Reach of Children

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

Stop Use and Ask a Doctor if

bleeding occurs

condition worsens

symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Qustions or Comments

Call 1 800 296-9067

Do Not Use

Do not use for the treatment of Diaper Rash. Consult Doctor.

Other Information

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2020 CVS Pharmacy

CVS.com

1 800 Shop CVS

Made in China

V-36582

This product is not manufactured or distributed by Pfizer, distributor of Preparation H Anti-itch Cream.

Packaging

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 1% 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MINERAL OIL (UNII: T5L8T28FGP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-081-01	1 in 1 BOX	06/23/2021
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/23/2021

Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)