HYDROCORTISONE 1% ANTI-ITCH CREAM- hydrocortisone cream

Hydrocortisone 1% Anti-Itch Cream by

Drug Labeling and Warnings

Hydrocortisone 1% Anti-Itch Cream by is a Otc medication manufactured, distributed, or labeled by DLC Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Fact

Active Ingredient

Hydrocortisone, USP 1%

Purpose

Antipruitic (Anti-Itch)

Uses

for the temporary relief of itching associated with minor skin irritation, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis

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

for the treatment of diaper rash. Consult a doctor.

for external feminine itching if you have a vaginal discharge. Consult a doctor.

When using this product

avoid contact with the eyes

do not use more than directed unless told to do so by a doctor

do not put this product into rectum by using fingers or any methanical devices or applicator

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occure again within a few days.

Do not begin use of any other hydrocotisone product unless you have consulted a doctor

rectal bleeding occurs

KEEP OUT OF THE 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.

Adults: for external anal itching: when practical, cleanse 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 application of this product

Children under 12 years of age: for external anal itching, consult a doctor

Other information

Store at room temperature

Inactive ingredients

Aloe barbadensis (aloe vera), Butyrospermum parkii (shea) butter, C12-15 alkyl benzoate, caprylic/capric triglyceride, cetearyl alcohol, cetearyl glucoside, cetyl alcohol, dimethicone, ethylhexylglycerin, glyceryl stearate, Persea gratissima (avocado) oil, phenoxyethanol, propylene glycol, Prunus amygdalus dulcis (sweet almond) oil, purified water, sodium polyacrylate, sodium stearoyl glutamate, tocopheryl acetate (vitamin E), xanthan gum.

Questions

1-800-858-3889

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Manufactured by

De La Cruz Products, A Division of DLC Laboratories, Inc. Paramount, CA 90723 USA

Principal Display

Maximum Strength

DeLaCruz®

Ages 2+ years

Hydrocortisone 1%

Anti-Itch Cream

For Rapid Relief of Itching,

Rashes & Skin Irritations

No Dyes, Fragrance Free

With Aloe Vera & 4 Moisturizer

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 1% ANTI-ITCH CREAM 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24286-1578
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
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.2 g  in 100 g
SHEA BUTTER (UNII: K49155WL9Y)	1 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	10 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O)	0.8 g  in 100 g
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)	0.6 g  in 100 g
CETYL ALCOHOL (UNII: 936JST6JCN)	2.5 g  in 100 g
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)	7 g  in 100 g
WATER (UNII: 059QF0KO0R)	65.65 g  in 100 g
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)	4 g  in 100 g
ALMOND OIL (UNII: 66YXD4DKO9)	1 g  in 100 g
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)	0.3 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.1 g  in 100 g
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)	2 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.9 g  in 100 g
AVOCADO OIL (UNII: 6VNO72PFC1)	0.1 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE)	0.3 g  in 100 g
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)	2.5 g  in 100 g
ALOE VERA LEAF POLYSACCHARIDES (UNII: W21O437517)	0.05 g  in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24286-1578-1	1 in 1 BOX	05/15/2024
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 Drug	M017	05/15/2024

Labeler - DLC Laboratories, Inc. (093351930)

Establishment
Name	Address	ID/FEI	Business Operations
DLC Laboratories, Inc.		093351930	manufacture(24286-1578)