Tact Cool Jelly

Dosage form: gel
Ingredients: diphenhydramine hydrochloride 2g in 100g, levomenthol 1g in 100g
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-704

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients

Diphenhydramine Hydrochloride 2.0%   
l-Menthol 1.0%

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.

Diphenhydramine Hydrochloride     External analgesic
l-Menthol                                             External analgesic

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TACT COOL  JELLY
diphenhydramine hydrochloride, levomenthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-704
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
diphenhydramine hydrochloride (diphenhydramine) diphenhydramine hydrochloride2 g  in 100 g
levomenthol (levomenthol) levomenthol1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
alcohol 
BUTYLATED HYDROXYTOLUENE  
CARBOMER HOMOPOLYMER TYPE C 
hydroxypropyl cellulose 
monoethanolamine 
NONOXYNOL-9 
polysorbate 80 
propylene glycol 
water 
Packaging
#Item CodePackage Description
1NDC:49873-704-011 TUBE (TUBE) in 1 CARTON
120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/02/1997
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture, label, pack

Revised: 12/2011
 
Sato Pharmaceutical Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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