Aveeno Restorative Skin Therapy Itch Relief Balm Cream
FDA Label NDC 69968-0637

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 Restorative Skin Therapy Itch Relief Balm (NDC 69968-0637). 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, active ingredient, purpose, use, warnings, 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

Active Ingredient

Pramoxine HCl (0.5%)

Purpose

External Analgesic

Use

For the temporary relief of itching associated with:

  • minor skin irritations

Warnings

For external use only.

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

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, 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

Questions?

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

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)

Principal Display Panel (113 g Tube Carton)

Principal Display Panel (113 g Tube Carton)

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