Active Ingredient (In Each Packet)
Colloidal Oatmeal, 100%
Soothing Bath Treatment
FDA Label NDC 49614-191
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medicine Shoppe International Inc for the product Soothing Bath Treatment (NDC 49614-191). 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
Package Information
NDC 49614-191-51
The Medicine Shoppe®
*Compare to active ingredient of Aveeno®
Soothing
Bath Treatment
Regular Formulation
100% Natural Colloidal Oatmeal
Skin Protectant
For fast temporary relief of itching , sore and sensitive skin due to:
Poison Ivy, Poison Sumac, Poison Oak, Insect Bites, Rashes and Eczema
TOTAL NET WEIGHT 12 oz (340 g)
8 INDIVIDUAL USE BATH PACKETS
1.5 oz. (42.5 g) EACH
*This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark, Aveeno®.
Distributed by Medicine Shoppe International, Inc.
St. Louis, MO 63132
www.medicineshoppe.com
A Cardinal Health Company
CIN# 3449774
The Medicine Shoppe®
*Compare to active ingredient of Aveeno®
Soothing
Bath Treatment
Regular Formulation
100% Natural Colloidal Oatmeal
Skin Protectant
For fast temporary relief of itching , sore and sensitive skin due to:
Poison Ivy, Poison Sumac, Poison Oak, Insect Bites, Rashes and Eczema
TOTAL NET WEIGHT 12 oz (340 g)
8 INDIVIDUAL USE BATH PACKETS
1.5 oz. (42.5 g) EACH
*This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark, Aveeno®.
Distributed by Medicine Shoppe International, Inc.
St. Louis, MO 63132
www.medicineshoppe.com
A Cardinal Health Company
CIN# 3449774
Image Of Carton (Pl 7107c O 4)
* Please review the disclaimer below.
