Label: MAXIMUM STRENGTH HYDROCORTISONE PLUS MOISTURIZING ALOE- hydrocortisone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81238-4608-1, 81238-4608-2 - Packager: Western First Aid Safety dba Aramark
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 21, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
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INDICATIONS & USAGE
Uses: • for the temporary relief of itching associated with minor skin irritations,
inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison
sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis
scrapes • for external genital, feminine, and anal itching • other uses of this product
should be only under the advice and supervision of a doctor -
WARNINGS
Warnings • for external use only • avoid contact with eyes • do not put this product
into rectum by using fingers or any mechanical device or applicator Consult a doctor:
• before use if you have a vaginal discharge (for external feminine itching) • for
external itching, do not exceed the recommended daily dosage or if bleeding occurs •
if condition When using this product: • avoid contact with eyes • do not put this
product into rectum by using fingers or any mechanical device or applicator worsens
or if symptoms persist for more than 7 days or clear up and occur again within a few
days • ask a doctor before use if you are using any other hydrocortisone product - DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions: • For 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, consult a
doctor • Adults for external anal itching when practical, cleanse the affected area with
mild soap and warm water and rinse thoroughly or by patting or blotting with an
appropriate cleansing pad • Gently dry by patting or blotting with toilet tissue or a
soft cloth before application of this product • Children under 12 years of age: for
external anal itching, consult a doctor - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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Product Package
aramark
25 ct. of 1g packets
Part # 608R23
MAXIMUM STRENGTH
HYDROCORTISONE
PLUS MOISTURIZING ALOEcompare to
Hydrocortisone1% ANTI-ITCH ANALGESIC • FOR THE
TEMPORARY RELIEFOF MINOR SKIN IRRITATIONS
Retain carton for complete product information
MANUFACTURED BY:
Aramark
Lenexa, KS 66219 (913) 269-9611aramarkuniform.com
25 Count
6 Count
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INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH HYDROCORTISONE PLUS MOISTURIZING ALOE
hydrocortisone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81238-4608 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81238-4608-1 25 in 1 BOX 04/16/2021 1 1 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:81238-4608-2 6 in 1 BOX 04/16/2021 2 1 g in 1 POUCH; 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 04/16/2021 Labeler - Western First Aid Safety dba Aramark (043861524) Registrant - Western First Aid Safety dba Aramark (043861524) Establishment Name Address ID/FEI Business Operations Yuyao Jessie Commodity Co., Ltd. 529892305 manufacture(81238-4608)