AVEENO ANTI ITCH CONCENTRATED- zinc oxide, ferric oxide red, and pramoxine hydrochloride lotion 
Johnson & Johnson Consumer 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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Aveeno Anti-Itch Concentrated Lotion

Drug Facts

Active ingredientPurposes
Calamine (3.%)Skin Protectant
Pramoxine HCl (1%)External Analgesic

Uses

  • For temporary relief of pain and itching associated with minor burns, sunburns, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak or poison sumac.
  • Dries the oozing and weeping of poison ivy/oak/sumac

Warnings

For external use only.

When using this product

  • Do not get into eyes

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days discontinue use and consult a doctor.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • 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: consult a doctor.

Other Information

Store at room temperature

Inactive ingredients

Avena Sativa (Oat) Kernel Extract, Avena Sativa (Oat) Kernel Flour, Avena Sativa (Oat) Kernel Oil, Camphor, Cetyl Alcohol, Dimethicone, Distearyldimonium Chloride, Glycerin, Isopropyl Palmitate, Methylparaben, Petrolatum, Sodium Chloride, Water

Questions?

1-866-428-3366

Dist. by: Johnson & Johnson
Consumer Products Company
Division of Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Dermatologist
Recommended

NEW
Formula!

Aveeno®
ACTIVE NATURALS®

Anti-Itch
CONCENTRATED LOTION

External Analgesic/Skin Protectant

Fast-Acting,
Soothing Itch Relief of:
Poison Ivy/Oak/Sumac,
Insect Bites

Soothes Chicken Pox Rash
And Allergic Itches

With Triple Oat Complex

4 fl. Oz. (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
AVEENO ANTI ITCH CONCENTRATED 
zinc oxide, ferric oxide red, and pramoxine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58232-9910
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide29.4 mg  in 1 mL
Ferric Oxide Red (UNII: 1K09F3G675) (Ferric Oxide Red - UNII:1K09F3G675) Ferric Oxide Red0.6 mg  in 1 mL
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Oat (UNII: Z6J799EAJK)  
Oatmeal (UNII: 8PI54V663Y)  
Oat Kernel Oil (UNII: 3UVP41R77R)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Dimethicone (UNII: 92RU3N3Y1O)  
Distearyldimonium Chloride (UNII: OM9573ZX3X)  
Glycerin (UNII: PDC6A3C0OX)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Methylparaben (UNII: A2I8C7HI9T)  
Petrolatum (UNII: 4T6H12BN9U)  
Sodium Chloride (UNII: 451W47IQ8X)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58232-9910-2118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/07/201212/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34811/07/201212/01/2023
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 1/2019
Document Id: df87c32e-1616-42a8-be12-ddc83cb9b199
Set id: 399664e9-8799-4a94-85bf-0c3825f42a0c
Version: 2
Effective Time: 20190103
 
Johnson & Johnson Consumer Inc.