Label: ANTI-ITCH WITH ALOE- hydrocortisone 1% cream
- NDC Code(s): 63868-688-01
- Packager: Chain Drug Marketing Association Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 23, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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INDICATIONS & USAGE
For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to
- insect bites
- eczema
- poison ivy
- poison oak
- poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external feminine genital and anal itching
- Other uses of this product should be only under the advice and supervision of a doctor.
- Warnings
- Stop use and ask a doctor
- Keep out of the reach of children
- Other information
- Inactive Ingredients
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When using this product
- Avoid contact with the eyes
- do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
- for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In the case of bleeding, stop use, consult a doctor.
- do not put this product into the rectum by using fingers or any mechanical device or applicator.
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Directions
Adults and children 2 years and older
- apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age
- do not use, consult doctor
For external and anal itching
- adults when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product.
- Children under 12 years of age with external anal ithcing consult a doctor.
- Distributed By
- Packaging
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INGREDIENTS AND APPEARANCE
ANTI-ITCH WITH ALOE
hydrocortisone 1% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-688 Route of Administration TOPICAL 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 SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) ALOE VERA LEAF (UNII: ZY81Z83H0X) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYSORBATE 60 (UNII: CAL22UVI4M) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PETROLATUM (UNII: 4T6H12BN9U) MINERAL OIL (UNII: T5L8T28FGP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-688-01 1 in 1 BOX 08/13/2020 1 28.3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/13/2020 Labeler - Chain Drug Marketing Association Inc. (011920774) Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)
