Aveeno Anti-itch Concentrated Lotion
FDA Label NDC 69968-0475

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Aveeno Anti-itch Concentrated (NDC 69968-0475). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: JOHNSON &
JOHNSON CONSUMER INC.
Skillman, NJ 08558

Otc - Purpose

Active ingredientsPurpose
Calamine 3%Skin Protectant
Pramoxine HCl 1%External Analgesic

Uses

  • For temporary relief of pain and itching associated with:
    • minor burns
    • sunburn
    • 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.

Do Not Use

  • on wounds or damaged skin

When Using This Product

  • do not get into eyes
  • do not bandage tightly

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

Otc - Keep Out Of Reach Of Children

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

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: ask a doctor.

Other Information

  • Store at Room Temperature

Inactive Ingredients

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

Questions?

call toll-free 866-428-3366 or 215-273-8755(collect) www.aveeno.com

Principal Display Panel - 118 Ml Bottle Label

Dermatologist
Recommended

Aveeno®

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

Aveeno®
Dermatologist recommended
for over 65 years

with Triple
Oat Complex

4 fl. oz. (118 mL)

Principal Display Panel (118 mL Bottle Label)

Principal Display Panel (118 mL Bottle Label)

* Please review the disclaimer below.