Indications and 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
CVS Anti-Itch Cream Hydrocortisone 1%
- Manufacturer
- Trifecta Pharmaceuticals Usa Llc
- Effective date
- 2024-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:44:57
Label at a glance#
ProductHydrocortisone 1%
Active ingredientHYDROCORTISONE
Label structure14 sections
Dosage and administration
●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.
Storage and handling
● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)
Contacts and useful links#
Label contents#
Full prescribing information#
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 4 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 4 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 4 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 4 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 4 |
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 |
|---|---|---|---|---|---|---|
| 69396-081-01 | Hydrocortisone 1% | 1 in 1 BOX | CREAM | 1 | 4 | |
| 69396-081-01 | Hydrocortisone 1% | 28 g in 1 TUBE | CREAM | 28 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hydrocortisone 1%
- Hydrocortisone
- GLYCERYL MONO AND DIPALMITOSTEARATE
- PROPYLPARABEN
- MINERAL OIL
- EDETATE DISODIUM
- PROPYLENE GLYCOL
- SORBITAN MONOSTEARATE
- METHYLPARABEN
- POLYSORBATE 60
- ALOE VERA LEAF
- CETYL ALCOHOL
- PETROLATUM
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69396-081 | 69396-081-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERYL MONO AND DIPALMITOSTEARATE | KC98RO82HJ | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITAN MONOSTEARATE | NVZ4I0H58X | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYSORBATE 60 | CAL22UVI4M | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| WATER | 059QF0KO0R | IACT |
| HYDROCORTISONE | WI4X0X7BPJ | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Hydrocortisone 1% | HYDROCORTISONE | Trifecta Pharmaceuticals Usa Llc | c58904b5-ec72-4cf6-e053-2a95a90a2bfc | 2024-12-18 | Warnings | 69396-081-01 69396-081 69396008101 299077a1-0e74-48ff-e063-6394a90a5246 c58904b5-ec72-4cf6-e053-2a95a90a2bfc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.