Allegra Topical Cream

Manufacturer
Chattem, Inc.
Effective date
2012-12-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:55:23

Label at a glance#

ProductAllegra Cooling Relief Anti-Itch
Active ingredientALLANTOIN, DIPHENHYDRAMINE HYDROCHLORIDE
Label structure19 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts- Cooling Relief

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 2%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • on chicken pox
  • on measles

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 2%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • on chicken pox
  • on measles

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.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 DIP...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 DIP...

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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 ...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 ...

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0Z2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD402
ALLANTOINACTIVE MOIETY344S277G0Z2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
DISTEARYLDIMONIUM CHLORIDEINACTIVE INGREDIENTOM9573ZX3X2
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV02
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL STEARATE CITRATEINACTIVE INGREDIENTWH8T92A0652
HYDROLYZED JOJOBA ESTERS (ACID FORM)INACTIVE INGREDIENTUDR641JW8W2
MAGNESIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT0R822556M52
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7I2
METHYL GLUCETH-20INACTIVE INGREDIENTJ3QD0LD11P2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M22
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
STEARETH-2INACTIVE INGREDIENTV56DFE46J52
STEARETH-21INACTIVE INGREDIENT53J3F32P582
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 50 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 329 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / RECTAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRA-ARTICULAR0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2POWDER, FOR SUSPENSION / ORAL0.01 mgExact identifier — unii candidate
15 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
68 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
15 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YAEROSOL, FOAM / TOPICAL37 mgExact identifier — unii candidate
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0SHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUPPOSITORY / VAGINALNAExact identifier — unii candidate
79 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
STEARETH-2STEARETH-2V56DFE46J5OINTMENT / TOPICAL714 mgExact identifier — unii candidate
4 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0INJECTION, SOLUTION / INTRAVENOUS2 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SUSPENSION / ORAL10 mgExact identifier — unii candidate
15 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPOWDER, FOR SUSPENSION / ORAL8 mgExact identifier — unii candidate
68 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHFILM / BUCCAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SUSPENSION / INTRATYMPANIC63 mgExact identifier — unii candidate
15 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PERIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCREAM / TOPICAL0.5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAVENOUS6 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TELIXIR / ORAL800 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET, EXTENDED RELEASE / ORAL0.12 mgExact identifier — unii candidate
68 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YTABLET, EXTENDED RELEASE / ORAL244 mgExact identifier — unii candidate
12 equally ranked IID candidates
POLOXAMER 407POLOXAMER 407TUF2IVW3M2SOLUTION / ORAL50 mg/5mlExact identifier — unii candidate
15 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c3464ade-e54f-4b64-b347-c1b5ecfae7f85375b99c-ad91-409f-850d-9ea0003b32d32012-12-01WarningsExact identifier
spl set id: 5375b99c-ad91-409f-850d-9ea0003b32d3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.