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  5. Label Information: Aveeno Restorative Skin Therapy Itch Relief Balm

FDA Label for Aveeno Restorative Skin Therapy Itch Relief Balm

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PRINCIPAL DISPLAY PANEL - 113 G TUBE CARTON

Aveeno Restorative Skin Therapy Itch Relief Balm Product Label

The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 - balm 01

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton - balm 01


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