Advisory opinion letter

Isl Theodore Heilg
President
Encl.

SKIN MATE"

MEDICATED PERSOKAL DEODORAKT SPRAY Contains Triamite-the new antibacterial agent.

Immediately effective-prevents odor all day.
Helps dry moisture.
Docs not clog skin pores.
Does not irritate skin.
Quick drying-non-sticky or gummy.
Does not stain clothing; or damage fabrics.

As an aerosol, it is completely sanitary-convenient to use by the whole family.

Body odor is a social matter-be i'ocial1y safe-obtain relief by using SKIN i.HATE :Medicated Personal Deodorant for that extra deodorant effectiveness.

10. Tests have proven SKIN MATE effective against 97% of bacteria nor­ mally found on the body.

::leets safety and effectiveness requirements of government agencies.

December 6, 1966
Regal Chemical Corporation
115 Dobbin Street
Brooklyn, Xew York 11222
Attention: Mr. Theodore Heilig
Gentlemen:

This is in reply to your letter of September 6 , 1966, regarding your "Code No. 3017 ::fedicated Personal Deodorant Spray. In our opinion, this proposed drug is not a new drug as defined in the Federal Food, Drug, and Cosmetic Act. \-Ve offer no objection to this formula­ tion under the proposed labeling.

Sincerely yours
/s/ .John F. Palmer
Assistant to the Director
for Industry Coordination
Bureau of Medicine
Food and Drug Administration

CODE NO. 3017
MEDICATED PERSONAL DEODORANT SPRAY
contains
TRIAMITE' , SURTENOL" , HEXACHLOROPHENE
ALCOHOL 40%

AXTIBACTERIAL INHIBITS THE GROWTH OF BODY ODOR

CAUSING BACTERIA
2 SECOND SPRAY HELPS PREVENT ODOR ALL DAY
DOES NOT DRIP, AND IS NOT STICKY OR MESSY
REFRESHING, COOLING & SOOTHI"G QUlCK DRYING
DRIES EXCESSIVE MOISTl'RE-UNDERARM OR FEET
DOES NOT HARM FABRICS
DIRECTIONS:

Hold about 6" from area to be sprayed (underarm or feet), point arrOW and push button.

WARNING:

Do not spray toward face. Do not app1y to broken or irritated skin. If rash deve10ps, discontinue use. Contents under pressure. Do not store near heat, or open flame. Exposure to temperatures over 130 Fahrenheit ADVISORY OPINIONS AND REQUESTS THEREFOR 1951

may cause bursting. Do not puncture. Never throw container into fire or incinerator. KEEP OUT OF CHILDREN' S REACH.

*Benzoic acid, n-propyl parahydroxybenzoate, parahydroxybenzoic acid trihydroxybenzoic acid (gallic).

equivalent to alkyl phenols , as amyl phenol 15% and aryl phenols, as phenyl phenols (0- and p- 0.45% Net contents oz.

Manufactured by Regal Chemical Corporation Brooklyn, N.

#3017