Label: EACH RELIEF EQUATE- diphenhydramine hci 2% gel

  • 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 January 20, 2017

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient                              Purpose
    Diphenhydramine HCI 2%................Topical analgesic

  • INDICATIONS & USAGE

    Uses Temporarily relieves pain due to: • minor burns • insect bites • sunburn • minor skin irritations • minor cuts • scrapes • rashes due to poison ivy, poison oak & poison sumac

  • PURPOSE

  • WARNINGS

    Warnings
    For external use only.
    Do not use • on large areas of the body • with any other product containing diphenhydramine, even one taken by mouth
    When using this product • avoid contact with the eyes
    Stop use and ask doctor if • condition gets worse • symptoms last more than 7 days • symptoms clear up and occur again in a few days.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions • do not use more than directed • 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.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Camphor, Citric Acid, Diazolidinyl
    Urea, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben,
    Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium
    Citrate, Water.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    EACH RELIEF  EQUATE
    diphenhydramine hci 2% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-246
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Glycerin (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    ALCOHOL (UNII: 3K9958V90M)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-246-03103 mL in 1 TUBE; Type 0: Not a Combination Product04/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/03/2017
    Labeler - Walmart (051957769)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(49035-246) , label(49035-246)
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!