FDA Label for Aveeno Anti-itch Concentrated

View Indications, Usage & Precautions

Aveeno Anti-itch Concentrated 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


Otc - Purpose



Active ingredientsPurpose
Calamine 3%Skin Protectant
Pramoxine HCl 1%External Analgesic

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

Warnings



For external use only.


Do Not Use



  • on wounds or damaged skin

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

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, Dimethicone, Camphor, Methylparaben, Sodium Chloride, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernal Flour, Avena Sativa (Oat) Kernel Extract


Questions?



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


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)


* Please review the disclaimer below.