Aveeno ®

Aveeno ®
SPL v6
SPL
SPL Set ID 07f4d4d0-9cee-46c3-bc71-2024abd31c9e
Route
TOPICAL
Published
Effective Date 2020-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (29.4 mg) Ferric Oxide Red (0.6 mg) Pramoxine (10 mg)
Inactive Ingredients
Water Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Cetyl Alcohol Dimethicone Methylparaben Sodium Chloride Oat Kernel Oil Oatmeal Oat

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-01

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 55105-1
Active ingredients Purpose
Calamine 3% Skin Protectant
Pramoxine HCl 1% External Analgesic
Warnings

For external use only.

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.
Do Not Use
  • on wounds or damaged skin
Questions?

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

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

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
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)


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
Calamine 3% Skin Protectant
Pramoxine HCl 1% External Analgesic
Warnings

For external use only.

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.
Do Not Use (Do not use)
  • on wounds or damaged skin
Questions?

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

Other Information (Other information)
  • Store at Room Temperature
Inactive Ingredients (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

When Using This Product (When using this product)
  • do not get into eyes
  • do not bandage tightly
Stop Use and Ask A Doctor If (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
Principal Display Panel 118 Ml Bottle Label (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)


Advanced Ingredient Data


Raw Label Data

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