better living brands llc hydrocortisone 1% drug facts

better living brands llc hydrocortisone 1% drug facts
SPL v2
SPL
SPL Set ID 9fe16fc5-77e3-47f5-a943-85bc6565c0d4
Route
topical
Published
Effective Date 2018-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (1 g)
Inactive Ingredients
aloe vera leaf oat levomenol indian frankincense shea butter cetyl alcohol dimethicone dipropylene glycol edetate disodium glycerin glyceryl monostearate isohexadecane magnesium ascorbyl phosphate maltodextrin methyl gluceth-20 methylparaben petrolatum phenoxyethanol polysorbate 60 propylparaben water vitamin a palmitate sodium citrate, unspecified form .alpha.-tocopherol acetate ginger

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-08-10

Purpose

Anti-itch

Description

Hydrocortisone 1%


Medication Information

Warnings

For external use only

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
Purpose

Anti-itch

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

Description

Hydrocortisone 1%

Do Not Use
  • for the treatment of diaper rash. Consult a doctor.
Active Ingredient

Hydrocortisone 1%

Questions Or Comments?

1-888-723-3929

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)

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)


Structured Label Content

Warnings

For external use only

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
Purpose

Anti-itch

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

Do Not Use (Do not use)
  • for the treatment of diaper rash. Consult a doctor.
Active Ingredient (Active ingredient)

Hydrocortisone 1%

Questions Or Comments? (Questions or comments?)

1-888-723-3929

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
Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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

Package/label Principal Display Panel (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)


Advanced Ingredient Data


Raw Label Data

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