Signature Care Hydrocortisone Lotion
FDA Label NDC 21130-166

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Signature Care Hydrocortisone (NDC 21130-166). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • temporarily relieves itching associated with minor skin irritations, rashes, and inflammation due to eczema
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do Not Use

  • for the treatment of diaper rash. Consult a doctor.

When Using This Product

  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor

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 hydrocortisone product unless you have asked a doctor

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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: ask a doctor

Other Information

  • store at 20-25°C (68-77°F)
  • contents filled by weight, not volume

Inactive Ingredients

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, bisabolol, boswellia serrata gum, butyrospermum parkii (shea butter) extract, cetyl alcohol, dextrin, dimethicone, dipropylene glycol, edetate disodium, glycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, magnesium ascorbyl phosphate, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 60, propylparaben, purified water, retinyl palmitate, sodium citrate, tocopheryl acetate, zingiber officinale (ginger) root extract

Questions Or Comments?

1-888-723-3929

Package/Label Principal Display Panel

Compare To Cortizone●10® Intensive Healing Lotion active ingredient

Quality Guaranteed

#1 DOCTOR RECOMMENDED ITCH RELIEF ACTIVE INGREDIENT

Hydrocortisone 1%

Anti-Itch Lotion

ECZEMA AND ITCHY, DRY SKIN

MAXIMUM STRENGTH

Fast, lasting itch relief

Clinically proven to moisturize 24 hours

With 7 intensive moisturizers

With botanicals and antioxidant vitamins A, C & E

NET WT 3.5 OZ (99 g)

* Please review the disclaimer below.