HYDROCORTISONE- cool relief gel with aloe gel

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Walgreens, Unipack LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Hydrocortisone 1%

Drug Facts

Purpose : Anti-itch

Drug Facts

Uses:

■ temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: ■ eczema ■ psoriasis ■ poison ivy, oak and sumac ■insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ temporarily relieves external anal and genital itching ■ other uses of this product should oonly be under the advise and supervison of a doctor

Warnings: For external use only

Warnings: For external use only

Do not use

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

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions

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 ■ If pregnant or breast-feeding: ask a health professional before use. ■ 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

Inactive ingredients:

Aloe extract, ascorbic acid, benzyl alcohol, ceteareth 20, cetearyl alcohol, cetyl palmitate, chamomile extract, glycerin, isopropyl myristate, isostearyl neopentanoate, methylparaben, PEG-40 stearate, petrolatum, purified water, sd 40 alcohol, vitamin A, vitamin D and vitamin E

SAFE HANDLING WARNING

TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Cool Relief Gel 1oz Tube

Cool Relief Gel 1oz

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
cool relief gel with aloe gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0363
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
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYL LACTATE, L- (UNII: 0379G9C44S)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)
ALCOHOL (UNII: 3K9958V90M)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
OAT (UNII: Z6J799EAJK)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ICODEXTRIN (UNII: 2NX48Z0A9G)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOHEXADECANE (UNII: 918X1OUF1E)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0363-01	1 in 1 CARTON	08/25/2023
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	08/25/2023

Labeler - Walgreens (008965063)

Registrant - Unipack LLC (116015769)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack LLC		009248480	manufacture(0363-0363)