Aveeno Calm Plus Restore Itch Relief Balm

Aveeno Calm Plus Restore Itch Relief Balm
SPL v2
SPL
SPL Set ID f17e2409-e8d7-37e0-e053-2a95a90a6026
Route
TOPICAL
Published
Effective Date 2023-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-03

Description

Drug Facts

Purpose

External Analgesic


Medication Information

Purpose

External Analgesic

Description

Drug Facts

Uses

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.

Section 50566-9

​​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
Section 50567-7

When using this product

  • Avoid contact with the eyes.
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?

866-428-3366; Outside US, dial collect 215-273-8755 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

Principal Display Panel 113g Tube Carton

NEW

Aveeno ®

Calm +

Restore

ITCH RELIEF

BALM

Pramoxine HCl external analgesic

Sensitive,

Delicate Skin

Instantly soothes

and helps relieve itch

FRAGRANCE FREE

DERMATOLOGIST RECOMMENDED BRAND

PREBIOTIC OAT, ALOE, PRO-VIT B5

net wt.

4 OZ (113 g)


Structured Label Content

Uses

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.

Section 50566-9 (50566-9)

​​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
Section 50567-7 (50567-7)

When using this product

  • Avoid contact with the eyes.
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?

866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

Active Ingredient (Active ingredient)

Pramoxine HCl (0.5%)

Other Information
  • Store at Room Temperature
Inactive Ingredients (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

Principal Display Panel 113g Tube Carton (PRINCIPAL DISPLAY PANEL - 113g Tube Carton)

NEW

Aveeno ®

Calm +

Restore

ITCH RELIEF

BALM

Pramoxine HCl external analgesic

Sensitive,

Delicate Skin

Instantly soothes

and helps relieve itch

FRAGRANCE FREE

DERMATOLOGIST RECOMMENDED BRAND

PREBIOTIC OAT, ALOE, PRO-VIT B5

net wt.

4 OZ (113 g)


Advanced Ingredient Data


Raw Label Data

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