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CONSUMER INC.
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Aveeno Calm Plus Restore Skin Therapy Balm Cream
FDA Label NDC 69968-0755
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 Calm Plus Restore Skin Therapy Balm (NDC 69968-0755). 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, uses, 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
Active Ingredient
Colloidal Oatmeal 1%
Purpose
Skin Protectant
Uses
Temporarily protects and helps relieve minor skin irritation and itching due to:
- rashes
- eczema
- poison ivy, oak, or sumac
- insect bites
Warnings
For external use only
When Using This Product
- Do not get into eyes
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
- Apply as needed.
Other Information
- Do not use if quality seal is broken or missing.
- Store at Room Temperature
Inactive Ingredients
Water, Glycerin, Panthenol, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Caprylic/Capric Triglyceride, Avena Sativa (Oat) Kernel Oil, Steareth-20, Benzalkonium Chloride, Ceramide NP, Avena Sativa (Oat) Kernel Extract, Sodium Chloride
Questions?
866-428-3366; Outside US, dial collect 215-273-8755
www.aveeno.com
Principal Display Panel - 48G Tube Carton
NEW!
Aveeno®
Calm +
Restore
SKIN THERAPY BALM
Colloidal Oatmeal Skin Protectant
Sensitive Skin
Soothes and deeply
moisturizes to help
strengthen skin’s
natural moisture barrier
STEROID FREE
FRAGRANCE-FREE
DERMATOLOGIST RECOMMENDED BRAND
COLLOIDAL OATMEAL + CERAMIDE
net wt. 1.7 oz (48 g)
Aveeno_001 (Aveeno 001)
* Please review the disclaimer below.
