ALLEGRA COOLING RELIEF ANTI-ITCH- diphenhydramine hcl, allantoin cream 
ALLEGRA INTENSIVE RELIEF ANTI-ITCH- diphenhydramine hcl, allantoin cream 
Chattem, Inc.

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.

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Allegra Topical Cream

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)

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 FINALpart34712/01/201210/23/2019
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 FINALpart34712/01/201210/23/2019
Labeler - Chattem, Inc. (003336013)

Revised: 12/2012
 
Chattem, Inc.