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SC Johnson will provide product-specific fragrance ingredients

BY Vivian Gomez

RACINE, Wis. — Expanding on its voluntary ingredient disclosure program, SC Johnson will begin disclosing air care fragrance ingredients present at the highest concentrations down to .09% of the product formula. The number of fragrance ingredients disclosed will vary by product but, on average, consumers should expect to find a range of 10 to 50 fragrance ingredients. Consumers will be able to access this information on WhatsInsideSCJohnson.com or by calling the SC Johnson consumer product helpline.
 
The consumer packaged goods company will begin to disclose product-specific fragrance ingredients in its air care products — including sprays, candles, oils and gels — initially in the U.S. and Canada, followed by Europe. The program will then expand into other SC Johnson product categories, including home cleaning. For those product categories outside of air care, where fewer fragrance ingredients are used, SC Johnson will list fragrance ingredients present at a concentration of more than .09% in the final product or the top 10 fragrance ingredients, whichever provides the most information for consumers. The company said that additional fragrance ingredients found in its products that are not disclosed are present at extremely low concentrations and will continue to be available via its online palette of fragrance ingredients.
 
SC Johnson brands include Glade, Kiwi, Off!, Pledge, Raid, Scrubbing Bubbles, Shout, Windex and Ziploc in the US, and Autan, Tana, Bama, Baygon, Brise, Kabikiller, Klear, Mr Muscle and Ridsect outside the US.
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Purdue Pharma launches new dosage of Butrans

BY Ryan Chavis

STAMFORD, Conn. — Purdue Pharma on Thursday announced the launch of a new dosage strength of 7.5 mcg/hour for its Butrans (buprenorphine) transdermal system CIII, bringing the total number of strengths offered by the company to five.
 
Butrans — a schedule III extended-release opioid — is the first transdermal system that delivers seven days of buprenorphine, according to the company. It may be called into the pharmacy, and refills may be given up to five times over the a six-month period, though refill guidelines may vary by state.
 
"We are proud to reach this milestone with the Butrans Transdermal System," said Todd Baumgartner, M.D., MPH, VP of research and development and chief medical officer at Purdue Pharma L.P. "The new 7.5 mcg/hour dosage strength can be an important tool for physicians managing the treatment of appropriate patients with chronic pain; the 7.5 mcg/hour dosage strength provides added flexibility when titrating from Butrans 5 mcg/hour." 
 
Butrans is used to manage pain that's severe enough to require daily, long-term opioid treatment. It was approved by the Food and Drug Administration in 2010. 
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FDA issues draft guidance on pediatric acetaminophen products

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration earlier this month issued draft guidance with several recommendations for manufacturers of acetaminophen products, designed to help minimize the risk to consumers of liver damage associated with the use of pediatric liquids containing acetaminophen.
 
"FDA's recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion," the agency noted in its announcement. "These recommendations apply to both single ingredient and combination ingredient OTC liquid oral drug products that are labeled for use by children under 12 years of age and contain acetaminophen."
 
According to the Acetaminophen Awareness Coalition, more than 50 million Americans use a medicine that contains acetaminophen — found in more than 600 different over-the-counter and prescription medicines including pain relievers, fever reducers, sleep aids and numerous cough, cold and flu medicines — each week. 
 
Among the recommendations made by FDA: 
 
  • All single-ingredient acetaminophen oral liquids for pediatric use should have a concentration of 160 mg acetaminophen per 5 mL;
  • For single-ingredient acetaminophen oral liquids, the statements “160 mg/5 mL” or “160 mg per 5 mL” should be prominently presented on the principal display panel of the container label and carton labeling immediately below or to the right of the active ingredient name (i.e., acetaminophen) and in the same font size as the active ingredient name;
  • The PDP should clearly indicate the age range and units of age (e.g., months or years) as stated in the Drug Facts Panel under the heading “Directions”;
  • The dosing directions in the Drugs Facts label should be provided only in milliliters (mL); and
  • The product package should include an appropriate dosage delivery device, such as a calibrated and labeled oral syringe or dosing cup that's calibrated in millileters (mL).
The Acetaminophen Awareness Coalition, a diverse group of leading health, healthcare provider and consumer organizations, formed the Know Your Dose campaign to educate consumers about safe acetaminophen use in order to prevent liver damage.
 
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