Indications and uses
Temporary relief of skin itching. The temporary relief of itching associated with minor skin irritations and rashes. Other uses of this product should be only under the advise and supervision of a doctor.
SKIN A COOL Hydrocortisone Anti-Itch Cream
- Manufacturer
- Ana-Cool, LLC
- Effective date
- 2023-11-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:59:57
Label at a glance#
ProductSKIN A COOL Hydrocortisone Anti-Itch
Active ingredientHYDROCORTISONE
Label structure8 sections
Dosage and administration
Apply to affected area not more than 3 to 4 times daily. Adults and children 2 years of age and older: Do not use, consult a doctor. Children under 2 years of age: When practical, cleanse the affected area "(selected one or both of the following: with mild soap and warm water and rinse thoroughly". or "by patting or blotting with an appropriate cleansing pad").: Adults: consult a doctor. Children under 12 years of...
Label contents#
Full prescribing information#
Active Ingredients:
Hydrocortisone 1.0%
Purpose
Anti-itch
Uses:
- Temporary relief of skin itching.
- The temporary relief of itching associated with minor skin irritations and rashes.
- Other uses of this product should be only under the advise and supervision of a doctor.
Warnings:
For external use only.
Do not use for
- for the treatment of diaper rash. Consult a doctor.
When using this product
- Avoid contact with the eyes.
- Do not exceed the recommended daily dosage unless directed by a doctor.
- In case of bleeding, consult a doctor promptly.
- Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop use and ask a doctor if
- condition worsens, or if 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 hydrocorstisone product unless you have consulted a doctor.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Apply to affected area not more than 3 to 4 times daily. Adults and children 2 years of age and older:
Do not use, consult a doctor. Children under 2 years of age:
When practical, cleanse the affected area "(selected one or both of the following: with mild soap and warm water and rinse thoroughly". or "by patting or blotting with an appropriate cleansing pad").: Adults:
consult a doctor. Children under 12 years of age:
Other Information:
Store at 20-25°C (68-77°F)
Inactive ingredients:
Aloe barbadensis (aloe vera gel) juice, aqua (deionized water), C12-15 alkyl benzoate, camellia sinensis (green tea) leaf extract, ceteareth-20, cetearyl alcohol, cetyl alcohol, ethylhexylglycerin, glycerin, glyceryl stearate, hamamelis virginiana (witch hazel) extract, helianthus annuus (sunflower) seed oil, PEG-100 stearate, petrolatum, phenoxyethanol, stearyl alcohol, tocopheryl acetate (vitamin E), zemea propanediol.
Questions?
visit: skin-a-cool.com
Package Labeling:
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70288-173-00 | SKIN A COOL Hydrocortisone Anti-Itch | 56.7 g in 1 BOTTLE, PUMP | CREAM | 56.7 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- SKIN A COOL Hydrocortisone Anti-Itch
- HYDROCORTISONE
- ALOE VERA LEAF
- WATER
- ALKYL (C12-15) BENZOATE
- GREEN TEA LEAF
- POLYOXYL 20 CETOSTEARYL ETHER
- CETOSTEARYL ALCOHOL
- CETYL ALCOHOL
- ETHYLHEXYLGLYCERIN
- GLYCERIN
- GLYCERYL MONOSTEARATE
- HAMAMELIS VIRGINIANA TOP
- SUNFLOWER OIL
- PEG-100 STEARATE
- PETROLATUM
- PHENOXYETHANOL
- STEARYL ALCOHOL
- .ALPHA.-TOCOPHEROL ACETATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70288-173 | 70288-173-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SKIN A COOL Hydrocortisone Anti-Itch | HYDROCORTISONE | Ana-Cool, LLC | e3ea7406-e494-4038-9b28-8d0a28b4b834 | 2023-11-10 | Warnings | 70288-173-00 70288-173 70288017300 09d7675e-8ab0-ac1b-e063-6394a90a58bb e3ea7406-e494-4038-9b28-8d0a28b4b834 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.