Label: FIRST AID ONLY HYDROCORTISONE 1% ANTI-ITCH- hydrocortisone cream

  • 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 August 3, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Hydrocortisone 1%

  • PURPOSE

    Anti-Itch

  • USES

    Uses ▪ temporarily relieves itching associated with minor skin irritations and rashes

    ▪other uses should be only under the advice and supervision of a doctor

  • WARNINGS

    For external use only.

    Do not use

    for a diaper rash. Consult a doctor.

    When using this product

    • Avoid contact with the eyes
    • Do not begin use of any other Hydrocortisone product unless you have asked a doctor

    Stop use and ask a doctor if

    ▪ condition worsens or symptoms persist for more than 7 days

    ▪ symptoms clear up and occur again within a few days

    Keep out of reach of children.If swallowed get medical help or contact poison control (800-222-1222) right away.

  • 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 Do not use, consult a doctor

  • OTHER INFORMATION

    • Store at 15° to 30°C (59° to 86°F)
  • INACTIVE INGREDIENTS

    ceteth-20, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, soft paraffin

  • SPL UNCLASSIFIED SECTION

    Questions 1.800.835.2263

  • PRINCIPAL DISPLAY PANEL

    Carton image Carton Image

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY HYDROCORTISONE 1% ANTI-ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5633(NDC:50382-024)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5633-0112 in 1 CARTON08/05/2022
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-5633-000.9 g in 1 PACKET; Type 0: Not a Combination Product08/05/2022
    3NDC:0924-5633-0225 in 1 CARTON08/05/2022
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/02/2012
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corpoation045924339relabel(0924-5633) , repack(0924-5633)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599repack(0924-5633) , relabel(0924-5633)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!