Active Ingredient (In Each Packet)
Colloidal Oatmeal, 100%
Soothing Bath Treatment
FDA Label NDC 50730-7100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Triad Group for the product Soothing Bath Treatment (NDC 50730-7100). 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 active ingredient (in each packet), purpose, use, warnings, otc - ask doctor/pharmacist, when using this product, stop use and ask doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Use
temporarily protects and helps relieve minor skin irritation and itching due to one or more of the following:
- rashes
- eczema
- poison ivy, oak, or sumac
- insect bites
Warnings
For external use only.
Otc - Ask Doctor/Pharmacist
When Using This Product
- do not get into eyes
- in some skin conditions, soaking too long may overdry
- to avoid slipping, use mat in tub or shower
Stop Use And Ask Doctor If
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Turn warm water faucet on to full force.
- Slowly sprinkle 1 packet of colloidal oatmeal directly under the faucet into the tub or container.
- Stir any colloidal oatmeal that may have settled to the bottom.
- Soak affected area for 15-30 minutes as needed or as directed by a doctor.
- Pat dry (do not rub) to keep a thin layer on the skin.
Other
Otc - Questions
Carton Information
Soothe and Bathe
*Compare to active ingredient of Aveeno®
Soothing
Bath Treatment
100% Colloidal Oatmeal
Skin Protectant
For fast, soothing relief of poison ivy, poison sumac, poison oak, insect bites, rashes and eczema
REGULAR FORMULA
Fragrance Free
8 Single use Packets - 1.5 oz. (42.5 g ) each
Total Net Wt. 12 oz. (340 g)
*This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark, Aveeno®.
Triad Group, Inc.
Brookfield, WI 53045
MADE IN USA
www.triad-group.net
Fragrance Free
Not Tested on Animals
*Compare to active ingredient of Aveeno®
Soothing
Bath Treatment
100% Colloidal Oatmeal
Skin Protectant
For fast, soothing relief of poison ivy, poison sumac, poison oak, insect bites, rashes and eczema
REGULAR FORMULA
Fragrance Free
8 Single use Packets - 1.5 oz. (42.5 g ) each
Total Net Wt. 12 oz. (340 g)
*This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark, Aveeno®.
Triad Group, Inc.
Brookfield, WI 53045
MADE IN USA
www.triad-group.net
Fragrance Free
Not Tested on Animals
Image Of Carton (Rt 7100c A)
* Please review the disclaimer below.
