United States of America 

FEDERAL TRADE COMMISSION 

Washington, DC 20580 

Division of Advertising Practices 

VIA ELECTRONIC MAIL 

Andrea C. Levine 

Senior Vice President, Director 

National Advertising Division 

112 Madison Avenue, 3rd Floor 

New York, NY 10016 

Dear Ms. Levine: 

May 13,2014 

I write to inform you of the results of our review into the advertising for the Salonpas 

Pain Relief Patch, the Salonpas Arthritis Pain Patch, and the Salonpas Gel Patch Hot. The 

National Advertising Division ("NAD") referred this matter to the Federal Trade Commission 

after Hisamitsu Pharmaceutical, Inc. ("Hisamitsu") declined to participate in an NAD review of 

its advertising based on a challenge brought by Pfizer Consumer Healthcare ("Pfizer"), the 

maker ofThermaCare Heatwraps. The core of Pfizer's challenge is that Hisamitsu advertises in 

a misleading way the literally true fact that the Salonpas Pain Relief Patch and Arthritis Pain 

Patch are the only over-the-counter ("OTC") medicated patches approved by FDA to relieve 

mild to moderate pain for up to twelve hours. 

1 

After reviewing this matter, we have determined not to recommend enforcement action at 

this time. As you know, our approach in all advertising cases is to first analyze the net 

impression created by the statements, graphics, and other depictions used in the advertising. We 

then look to whether the advertiser has a " reasonable basis" for its objective product claims. In 

this case, absent extrinsic evidence to the contrary, we do not believe that the overall net 

impression ofHisamitsu's advertisements is misleading. 

In declining to participate, Hisamitsu argued that the "FDA Approval," "mild to moderate 

pain," and "up to 12 hours" effectiveness claims were not within NAD's mandate, as they were 

"expressly approved by federal law or regulation" by virtue of FDA's approval of the new drug 

application for the Salonpas Pain Relief Patch and Arthritis Pain Patch. In its decision, NAD 

concluded that the challenged claims are within its purview of review because they are not 

limited to representations that the products are "FDA approved" but also include comparative 

pain relief and "#1 Brand" claims. We also note that literally true claims regarding the Salonpas 

FDA approval, indication of pain relief, and duration of pain relief could be presented in a 

misleading fashion and those claims would certainly be within NAD's purview of review, as 

they would be within ours. 
Andrea C. Levine, Esq. 

May 13,2014 

Page 2 

Hisamitsu's ads have compared the efficacy of the Salonpas Pain Relief Patch and 

Arthritis Pain Patch to OTC drugs, such as medicated patches and oral pain reliefmedications.2 

The ads draw attention to the fact that the Salonpas Pain Relief Patch and Arthritis Pain Patch are 

unique among competing OTC pain relief drugs because they are FDA-approved and labeled to 

relieve a higher indication of pain, moderate pain (versus minor pain), for up to twelve hours. 

Hisamatu's ads do not mention ThermaCare Heatwraps, a non-medicated device that provides 

pain relief through heat therapy, and we believe any comparisons implicit in these ads are with 

other medicated products. 

Pfizer's argument that Hisamatsu is comparing itself to ThermaCare Heatwraps rests 

almost entirely on the close proximity of the two products on store shelves. We find Pfizer's 

argument unpersuasive in this instance. The materials Pfizer submitted show that the Salonpas 

pain relief patches are placed in just as close proximity, and in many instances closer proximity, 

to the competing medicated products actually referred to in Hisamatsu's advertising, than to the 

ThermaCare Heatwraps. We believe consumers viewing these products on the shelves will 

understand the significant differences between medicated patches that contain menthol and 

methyl salicylate versus a non-medicated, air-activated wrap that provides heat therapy. 

Pfizer also contested Hisamitsu's FDA-approved claims, including the representation that 

"Salonpas is the first and only OTC pain patch clinically-proven and FDA-approved to relieve 

tough pain for up to 12 hours" because it believes that the FDA approval statement suggests that 

FDA has endorsed Salonpas versus competing products, including ThermaCare Heatwraps. We 

disagree. These and similar representations merely emphasize the fact that the Salonpas Pain 

Relief Patch and Arthritis Pain Patch are the only patches to receive FDA approval and that their 

effectiveness in temporarily relieving more intense aches and pains was clinically proven during 

FDA's review. We do not interpret this and similar representations to imply that FDA has 

endorsed Salonpas versus competing products. 

Pfizer further questioned Hisamitsu's claims that Salonpas patches are the "#1 brand of 

patches in the world," the "largest brand of pain relief patches in the U.S.," and the "#1 pain 

patch worldwide and in the U.S.," maintaining that these statements convey the false message 

that Salonpas is "# 1" because consumers believe it offers superior efficacy versus competing 

patches and wraps. We believe these claims simply convey the message that Salonpas patches 

are the bestselling patches, and not that consumers recognize Salonpas as a more effective pain 

reliever than competing products. 

Finally, Pfizer challenged Hisamitsu's claim that the Salonpas Gel Patch Hot, which is 

unapproved, "soothes on contact" because it believes this claim implies immediate relief upon 

application of the patch to the site of pain. We note that on its website, Hisamitsu claims that the 

Salonpas Gel Patch Hot, " [s]tarts to cool on contact. Gel Patch Technology soothes the pain 

away and menthol cools on contact then delivers deep penetrating waves of heat. Capsaicin, the 

2 Hisamitsu's print and website advertisements compare these patches to Icy Hot Patch, 

Bengay Pain Relief Patch, Advil, and Tylenol Extra Strength. 
Andrea C. Levine, Esq. 

May 13,2014 

Page 3 

actives in chili peppers, extends the pain relief for long lasting relief." We believe the net 

impression of this ad is that the gel patch provides an immediate cooling sensation, not 

instantaneous pain relief. While other advertisements claim that the gel patch "soothes on 

contact," we believe this phrase also denotes an instant cooling effect. 

We regret that Hisamitsu chose not to participate in the NAD process because we fully 

support the self-regulatory process. However, for the foregoing reasons, the staff has determined 

not to take additional action at this time. We appreciate receiving your referral and having the 

opportunity to review this matter. 

cc: Daniel J. Manelli, Esq. 

Manelli & Fisher, PLLC 

Ross M. Weisman, Esq. 

Ann Marie Therese Wahls, Esq. 

Kirkland & Ellis LLP