FDA Label for Soothing Bath Treatment

View Indications, Usage & Precautions

Soothing Bath Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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.

Active Ingredient (In Each Packet)



Colloidal Oatmeal, 100%


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 37205-178-51

LEADER                          SATISFACTION GUARANTEED

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

*Compare to active ingredient of Aveeno®

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 Cardinal Health
Dublin, OH 43017
CIN 2434504
www.myleader.com
MADE IN USA

All Leader Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.



* Please review the disclaimer below.