Label: INTENSIVE HEALING ANTI ITCH- hydrocortisone cream
- NDC Code(s): 11822-0416-1
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- poison ivy, oak, sumac
- insect bites
- seborrheic dermatitis
- temporarily relieves external anal and genital itching
- other uses of this product should only be under the advice and supervision of a doctor
For external use only
Do not use
- for the treatment of diaper rash. Ask a doctor.
- in the genital area if you have a vaginal discharge. Ask a doctor.
When using this product
- avoid contact with the 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
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.
If swallowed, get medical help or contact a Poison Control Center right away.
- 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: do not use, ask a doctor
- 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
- Other information
- store at 20°-25°C (68°-77°F)
- Inactive ingredients
aloe barbadensis leaf juice, avena sativa (oat) kernel extract, benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, diazolidinyl urea, dimethicone, distearyldimonium chloride, edetate disodium, glycerin, glyceryl monostearate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, jojoba esters, magnesium ascorbyl phosphate, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, potassium hydroxide, PPG-12/SMDI copolymer, propylparaben, purified water, retinyl palmitate, stearamidopropyl PG-dimonium chloride phosphate, steareth-2, steareth-21, stearyl alcohol, tocopheryl acetateClose
- Questions or comments?
- Principal Display Panel
Compare to the active ingredient of Cortizone●10® Intensive Healing Formula
CLINICALLY PROVEN TO MOISTURIZE 24 HOURS
intensive healing anti-itch cream
relieves itch fast
temporarily relieves dry, itchy skin, rashes, insect bites, eczema & psoriasis, inflammation, irritation & redness
calms, nourishes, hydrates
safe for sensitive skin
with antioxidants & chamomile
NET WT 1 OZ (28 g)
enriched with vitamins A, C & EClose
- INGREDIENTS AND APPEARANCE
INTENSIVE HEALING ANTI ITCH
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0416 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) OAT (UNII: Z6J799EAJK) BENZYL ALCOHOL (UNII: LKG8494WBH) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) CHAMOMILE (UNII: FGL3685T2X) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DIMETHICONE (UNII: 92RU3N3Y1O) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) METHYL GLUCETH-20 (UNII: J3QD0LD11P) METHYLPARABEN (UNII: A2I8C7HI9T) PETROLATUM (UNII: 4T6H12BN9U) POLYSORBATE 60 (UNII: CAL22UVI4M) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) STEARETH-2 (UNII: V56DFE46J5) STEARETH-21 (UNII: 53J3F32P58) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Product Characteristics Color WHITE (Off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0416-1 1 in 1 CARTON 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/20/2014 Labeler - Rite Aid Corporation (014578892)