Walgreens Hydrocortisone Cool Relief Gel

Walgreens Hydrocortisone Cool Relief Gel
SPL v3
SPL
SPL Set ID 1ae2b37d-d5b2-74d2-e063-6294a90a0de0
Route
TOPICAL
Published
Effective Date 2023-08-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Anhydrous Trisodium Citrate Dimethicone Methyl Lactate, L- Methyl Gluceth-20 Ppg-3 Benzyl Ether Myristate Alcohol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Maltodextrin Oat Water Aloe Vera Leaf Edetic Acid Icodextrin Polysorbate 60 Propylparaben Isohexadecane Methylparaben Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-25

Description

Active Ingredients Hydrocortisone 1%


Medication Information

Description

Active Ingredients Hydrocortisone 1%

Section 50741-8

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

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

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.

Drug Facts

Active Ingredients

Hydrocortisone 1%

Cool Relief Gel 1oz

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

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

Cool Relief Gel 1oz Tube

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

Warnings: for External Use Only

Warnings: For external use only


Structured Label Content

Section 50741-8 (50741-8)

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

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

Do Not Use (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.

Drug Facts

Active Ingredients

Hydrocortisone 1%

Cool Relief Gel 1oz

Inactive Ingredients: (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

When Using This Product (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

Cool Relief Gel 1oz Tube

Stop Use and Ask A Doctor If (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)

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

Warnings: for External Use Only (Warnings: For external use only)

Warnings: For external use only


Advanced Ingredient Data


Raw Label Data

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