Aveeno ®

Aveeno ®
SPL v5
SPL
SPL Set ID 61824ca7-a2d3-4830-b2bb-149a3222bfc8
Route
TOPICAL
Published
Effective Date 2020-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pramoxine (5 mg)
Inactive Ingredients
Glycerin Distearyldimonium Chloride Petrolatum Isopropyl Palmitate Water Cetyl Alcohol Panthenol Dimethicone Oatmeal Benzyl Alcohol Chlorphenesin Steareth-20 Aloe Vera Leaf Sodium Chloride Oat

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-01

Description

Drug Facts

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Drug Facts

Use

For the temporary relief of itching associated with:

  • minor skin irritations
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.

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.
Questions?

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

Active Ingredient

Pramoxine HCl (0.5%)

Other Information

Store at Room Temperature

Inactive Ingredients

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Panthenol, Dimethicone, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Cetyl Hydroxyethylcellulose, Chlorphenesin, Steareth-20, Aloe Barbadensis Leaf Extract, Sodium Chloride, Avena Sativa (Oat) Kernel Extract

When Using This Product
  • Avoid contact with the 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
Principal Display Panel 113 G Tube Carton

DERMATOLOGIST RECOMMENDED

NEW

Aveeno ®

RESTORATIVE

SKIN THERAPY


SENSITIVE, DISTRESSED, DRY SKIN

Itch Relief Balm

Pramoxine HCL external analgesic

prebiotic oat

concentrate,

aloe & pro-vit B5


instantly soothes

& helps relieve itch

net wt. 4 oz (113g)


Structured Label Content

Use

For the temporary relief of itching associated with:

  • minor skin irritations
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.

Purpose

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.
Questions?

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

Active Ingredient

Pramoxine HCl (0.5%)

Other Information

Store at Room Temperature

Inactive Ingredients

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Panthenol, Dimethicone, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Cetyl Hydroxyethylcellulose, Chlorphenesin, Steareth-20, Aloe Barbadensis Leaf Extract, Sodium Chloride, Avena Sativa (Oat) Kernel Extract

When Using This Product (When using this product)
  • Avoid contact with the eyes.
Stop Use and Ask A Doctor If (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
Principal Display Panel 113 G Tube Carton (PRINCIPAL DISPLAY PANEL - 113 g Tube Carton)

DERMATOLOGIST RECOMMENDED

NEW

Aveeno ®

RESTORATIVE

SKIN THERAPY


SENSITIVE, DISTRESSED, DRY SKIN

Itch Relief Balm

Pramoxine HCL external analgesic

prebiotic oat

concentrate,

aloe & pro-vit B5


instantly soothes

& helps relieve itch

net wt. 4 oz (113g)


Advanced Ingredient Data


Raw Label Data

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