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CONSUMER INC.
Skillman, NJ 08558
Aveeno Calm Plus Restore Itch Relief Balm Cream
FDA Label NDC 69968-0796
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 Itch Relief Balm (NDC 69968-0796). 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, otc - when using, otc - stop use, 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
Pramoxine HCl (0.5%)
Purpose
External Analgesic
Uses
For the temporary relief of itching associated with:
- minor skin irritations
Warnings
For external use only.
Otc - When Using
When using this product
- Avoid contact with the eyes.
Otc - Stop Use
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?
866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com
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)
Aveeno_01 (Aveeno 01)
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