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Tact Cool

Sato Pharmaceutical Co., Ltd.

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients

Diphenhydramine Hydrochloride 2.0%   
l-Menthol 1.0%

Uses

Uses

temporarily relieves pain and itching associated with
■insect bites    ■minor skin irritations    ■minor cuts
■scrapes    ■rashes due to poison ivy    ■sunburn    ■minor burns

Warnings
For external use only

When using this product
■avoid contact with the eyes

Stop use and ask a doctor if
■condition worsens    ■symptoms persist for more than 7 days.
■symptoms clear up and occur again within a few days.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions
■Adults and children 2 years and over: Apply to affected area not more than 3 to 4 times daily.  ■Children under 2 years: Ask a doctor.

Inactive ingredients  alcohol, BHT, carboxyvinyl polymer, hydroxypropyl cellulose, monoethanolamine, nonoxynol 9, polysorbate 80, propylene glycol, purified water.

Purpose

Diphenhydramine Hydrochloride     External analgesic
l-Menthol                                             External analgesic

tactcjPDP.jpgTact Cool

tactcjcart.jpgTact Cool

Tact Cool

diphenhydramine hydrochloride, levomenthol GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49873-704
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 2 g
LEVOMENTHOL 1 g

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
BUTYLATED HYDROXYTOLUENE
CARBOMER HOMOPOLYMER TYPE C
hydroxypropyl cellulose
MONOETHANOLAMINE
NONOXYNOL-9
polysorbate 80
propylene glycol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 TUBE
2 NDC:49873-704-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 1997-10-02


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Be sure to consult your doctor before taking any medication!
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