Label: ALLEGRA COOLING RELIEF ANTI-ITCH- diphenhydramine hcl, allantoin cream
ALLEGRA INTENSIVE RELIEF ANTI-ITCH- diphenhydramine hcl, allantoin cream

  • NDC Code(s): 41167-4255-0, 41167-4255-2, 41167-4255-9, 41167-4266-0, view more
    41167-4266-2, 41167-4266-9
  • Packager: Chattem, 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 April 17, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts- Cooling Relief

  • Active ingredients

    Allantoin 0.5%

  • Purpose

    Skin protectant

  • Active ingredients

    Diphenhydramine hydrochloride 2%

  • Purpose

    Topical analgesic

  • Uses

    • temporarily relieves pain and itching associated with:
      ▪ insect bites
      ▪ minor skin irritations
      ▪ sunburn
      ▪ rashes due to poison ivy, poison oak or poison sumac
      ▪ minor burns
      ▪ minor cuts
      ▪ scrapes
    • temporarily protects and helps relieve chapped or cracked skin
  • Warnings

    For external use only

    Do not use on

    • more than directed
    • on large areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth
    • on deep or puncture wounds
    • on animal bites
    • on serious burns
    • on serious sunburn or broken, blistered or oozing skin

    Ask a doctor before use

    • on chicken pox
    • on measles

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding,

    Ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not use more than directed
    • adults and children 2 years and older: apply freely to affected area as needed but no more than 3 or 4 times daily
    • children under 2 years: ask a doctor
  • Inactive ingredients

    water, glycerin, petrolatum, ethanol, dimethicone, jojoba esters, menthyl lactate, cetyl alcohol, emulsifying wax, modified phospholipid, aloe vera leaf juice, stearyl alcohol, distearyldimonium chloride, poloxamer 407, steareth-21, steareth-2, glyceryl stearate, hydrolyzed jojoba esters, methyl gluceth-20, phenoxyethanol, methylparaben, tocopheryl acetate, propylparaben, EDTA, potassium hydroxide, magnesium ascorbyl phosphate, retinyl palmitate (304-79)

    Drug Facts- Intensive Relief

  • Active ingredients

    Allantoin 0.5%

  • Purpose

    Skin protectant

  • Active ingredients

    Diphenhydramine hydrochloride 2%

  • Purpose

    Topical analgesic

  • Uses

    • temporarily relieves pain and itching associated with:
      ▪ insect bites
      ▪ minor skin irritations
      ▪ sunburn
      ▪ rashes due to poison ivy, poison oak or poison sumac
      ▪ minor burns
      ▪ minor cuts
      ▪ scrapes
    • temporarily protects and helps relieve chapped or cracked skin
  • Warnings

    For external use only

    Do not use on

    • more than directed
    • on large areas of the body
    • with any other product containing diphenhydramine, even one taken by mouth
    • on deep or puncture wounds
    • on animal bites
    • on serious burns
    • on serious sunburn or broken, blistered or oozing skin

    Ask a doctor before use

    • on chicken pox
    • on measles

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding,

    Ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • do not use more than directed
    • adults and children 2 years and older: apply freely to affected area as needed but no more than 3 or 4 times daily
    • children under 2 years: ask a doctor
  • Inactive ingredients

    water, glycerin, petrolatum, ethanol, dimethicone, jojoba esters, menthyl lactate, cetyl alcohol, emulsifying wax, modified phospholipid, aloe vera leaf juice, stearyl alcohol, distearyldimonium chloride, poloxamer 407, steareth-21, steareth-2, glyceryl stearate, hydrolyzed jojoba esters, methyl gluceth-20, phenoxyethanol, methylparaben, tocopheryl acetate, propylparaben, EDTA, potassium hydroxide, magnesium ascorbyl phosphate, retinyl palmitate (304-77)



  • PRINCIPAL DISPLAY PANEL

    NEW!
    Cools Itch Fast
    for skin use only
    MAXIMUM STENGTH
    DIPHENHYDRAMINE
    plus ALLANTOIN
    Cooling Relief
    Anti-Itch CREAM
    Histamine-Blocker
    Topical Analgesic/Skin Protectant
    Net wt 1 oz (28.3 g)

    NEW!
Cools Itch Fast
for skin use only
√ Relieves Hot, Itchy Skin
√ Insect Bites
√ Cools on Contact
√ Poison Ivy, Oak & Sumac
√ Minor Cuts & Scrapes
Allegra®
MAXIMUM STENGTH
DIPHENHYDRAMINE
plus ALLANTOIN
Cooling Relief
Anti-Itch CREAM
Histamine-Blocker
Topical Analgesic/Skin Protectant
Net wt 1 oz (28.3 g)

  • PRINCIPAL DISPLAY PANEL

    NEW!
    Relieves Itch Fast
    for skin use only
    Allegra®
    MAXIMUM STENGTH
    DIPHENHYDRAMINE
    plus ALLANTOIN
    Intensive Relief
    Anti-Itch CREAM
    Histamine-Blocker
    Topical Analgesic/Skin Protectant
    Net wt 1 oz (28.3 g)

    NEW!
Relieves Itch Fast
for skin use only
√ All Day Moisturizers
√ Insect Bites
√ Relieves Dry, Irritated & Cracked Skin
√ Poison Ivy, Oak & Sumac
√ Works at the Source of Itch
√ Minor Cuts & Scrapes
Allegra®
MAXIMUM STENGTH
DIPHENHYDRAMINE
plus ALLANTOIN
Intensive Relief
Anti-Itch CREAM
Histamine-Blocker
Topical Analgesic/Skin Protectant
Net wt 1 oz (28.3 g)

  • INGREDIENTS AND APPEARANCE
    ALLEGRA COOLING RELIEF ANTI-ITCH 
    diphenhydramine hcl, allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4255
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARETH-2 (UNII: V56DFE46J5)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-4255-91 in 1 CARTON12/01/201211/29/2018
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41167-4255-01 in 1 CARTON12/01/201211/29/2018
    228.3 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:41167-4255-21 in 1 CARTON12/01/201204/15/2018
    356.6 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34712/01/2012
    ALLEGRA INTENSIVE RELIEF ANTI-ITCH 
    diphenhydramine hcl, allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-4266
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 g
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARETH-2 (UNII: V56DFE46J5)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-4266-91 in 1 CARTON12/01/201204/21/2019
    114 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:41167-4266-01 in 1 CARTON12/01/201210/23/2019
    228.3 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:41167-4266-21 in 1 CARTON12/01/201204/15/2018
    356.6 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34712/01/2012
    Labeler - Chattem, Inc. (003336013)