OTC Medication Information: Aveeno Anti-Itch Concentrated

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.

Drug Facts

Active ingredients Purpose
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

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

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

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
(click image for full-size original)
AVEENO ANTI-ITCH CONCENTRATED
zinc oxide, ferric oxide red, and pramoxine hydrochloride lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0475
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 29.4 mg in 1 mL
FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED 0.6 mg in 1 mL
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
DISTEARYLDIMONIUM CHLORIDE
PETROLATUM
ISOPROPYL PALMITATE
CETYL ALCOHOL
DIMETHICONE
METHYLPARABEN
SODIUM CHLORIDE
OAT KERNEL OIL
OATMEAL
OAT
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69968-0475-4 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 03/01/2019
Labeler — Johnson & Johnson Consumer Inc. (118772437)

Revised: 01/2023 Johnson & Johnson Consumer Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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