Label: ITCH AND BITE RELIEF FIRST AID KIT- hydrocortisone and diphenhydramine kit
ITCH AND BITE RELIEF FIRST AID KIT- hydrocortisone and diphenhydramine hydrochloride kit

  • NDC Code(s): 47682-167-46, 47682-184-46, 49035-057-09, 49035-588-09, view more
    61010-5800-1
  • Packager: WAL-MART STORES, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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, 2021

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  • Active ingredient (Hydrocortisone Cream)

    Hydrocortisone 1.0%

  • Purpose(Hydrocortisone Cream)

    Anti-itch

  • Uses (Hydrocortisone cream)

    • For temporary relief of itching associated with minor skin irritations, inflammation, or rashes due to:

    • eczemas

    • insect bites

    • poison ivy, oak or sumac

    • soaps

    • detergents

    • cosmetics

    • jewelry

    • seborrheic dermatitis

    • psoriasis

    • Other uses of product should be only under the advice and supervision of a doctor.

  • Warnings(Hydrocortisone Cream)

    For external use only

    Do not use (Hydrocortisone cream)

    • in the eyes

    • for treatment of diaper rash

    • for feminine itching

    Ask a doctor before use if you are (Hydrocortisone cream)

    • using any other hydrocortisone product

    Stop use and ask a doctor if (Hydrocortisone cream)

    the condition worsens or lasts more than 7 days, or clears up and occurs again within a few days

    Keep out of reach of children (Hydrocortisone cream)

    If ingested, contact a Poison Control Center right away

  • Directions (Hydrocortisone cream)

    • Apply to affected area not more than 3 to 4 times daily

    • Children under 2: ask a doctor

  • Other information (Hydrocortisone cream)

    • Store at room temperature (do not freeze)

    • Do not use any opened or torn packets

  • Inactive ingredients(Hydrocortisone cream)

    emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

  • Active ingredient (in each caplet)(Diphen caplet)

    Diphenhydramine Hydrochloride 25 mg

  • Uses (Diphen caplet)

    Temporarily relieves these symptoms due to hay fever or other respiratory allergies

    • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes

    Temporarily relieves these symptoms due to the common cold

    • runny nose • sneezing

  • Warnings (Diphen caplet)

    Do not use

    • to make children sleepy

    • with any other product containing diphenhydramine, even one that is used on skin.

    Ask a doctor before use if you have (Diphen caplet)

    • a breathing problem such as emphysema or chronic bronchitis

    • difficulty in urination due to enlargement of the prostate gland

    • glaucoma

    When using this product (Diphen caplet)

    • marked drowsiness may occur

    • avoid alcohol beverages

    • alcohol, sedatives and tranquilizers may increase the drowsiness effect

    • use caution when driving a motor vehicle or operating machinery

    • excitability may occur, especially in children

    If pregnant or breast-feeding (Diphen caplet)

    ask a health care professional before use.

    Keep out of reach of children (Diphen caplet)

    n case of overdose, contact a physician or poison control center immediately.

  • Directions (Diphen caplet)

    • do not take more than directed

    Adults and children (12 years and older): Take 1 to 2 caplets every 4 to 6 hours as needed. Do not take more than 12 caplets in 24 hours, or as directed by a doctor.

    Children under 12 years: Do not give to children under 12 years of age.

  • Other information (Diphen caplet)

    • each caplet may contain: calcium 25mg

    • store at room temperature 59º to 86ºF (15º to 30ºC)

    • protect from light

    • use by expiration date on packet

    • tamper-evident sealed packetsM

    • do not use any opened or torn packets

  • Inactive ingredients (Diphen caplet)

    carnauba wax*, colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dicalcium phosphate*, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate*, titanium dioxide

    * may contain

  • First Aid Kit Package/Label Principal Display Panel

    OZARK TRAIL

    OUTDOOR EQUIPMENT

    ITCH & BITE RELIEF

    FIRST AID KIT

    • Ideal for minor insects bites and itches

    9 PIECES

    SEE BACK PANEL FOR KIT CONTENTS

    package label

  • First Aid Kit Pakcage/Label Principal Display Panel

    OZARK TRAIL

    OUTDOOR EQUIPMENT

    ITCH & BITE RELIEF

    FIRST AID KIT

    Ideal for minor insects bites and itches

    9 PIECES

    SEE BACK PANEL FOR KIT CONTENTS

    LABEL

  • INGREDIENTS AND APPEARANCE
    ITCH AND BITE RELIEF FIRST AID KIT 
    hydrocortisone and diphenhydramine kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-057
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-057-091 in 1 CASE; Type 0: Not a Combination Product09/09/202003/12/2025
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 POUCH 3.6 g
    Part 24 PACKET 4 
    Part 1 of 2
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Item Code (Source)NDC:61010-5800
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-5800-10.9 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart348
    Part 2 of 2
    MEDIQUE DIPHEN 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Item Code (Source)NDC:47682-167
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    LACTOSE (UNII: J2B2A4N98G)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorpink (pink) Scoreno score
    ShapeOVAL (oval) Size11mm
    FlavorImprint Code 048;D
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-167-461 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart341
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34809/09/202003/12/2025
    ITCH AND BITE RELIEF FIRST AID KIT 
    hydrocortisone and diphenhydramine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-588
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-588-091 in 1 CASE; Type 0: Not a Combination Product10/30/201903/12/2025
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 14 POUCH 3.6 g
    Part 24 PACKET 4 
    Part 1 of 2
    HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Item Code (Source)NDC:61010-5800
    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
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-5800-10.9 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart348
    Part 2 of 2
    MEDIQUE DIPHEN 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Item Code (Source)NDC:47682-184
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Colorpink (pink) Scoreno score
    ShapeOVAL (oval) Size11mm
    FlavorImprint Code 061;T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-184-461 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart341
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/30/201903/12/2025
    Labeler - WAL-MART STORES, INC. (051957769)
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