FDA Label for Tact

View Indications, Usage & Precautions

Tact Product Label

The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Inc., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredients  
Diphenhydramine hydrochloride 2.0%
Menthol 1.0%


Otc - Purpose



Purpose   
Diphenhydramine Hydrochloride    External analgesic
l-Menthol    External analgesic


Indications & Usage



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


Warnings



Warnings
For rectal use only


Otc - When Using



When using this product
■ avoid contact with the eyes


Otc - Stop Use



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.


Otc - Keep Out Of Reach Of Children



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


Dosage & Administration



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 Ingredient



Inactive ingredients  butylparaben, carboxyvinyl polymer, cetyl alcohol, diethanolamine, edetate disodium, light mineral oil, PEG-40 stearate, propylene glycol, propylparaben, purified water, sorbitan monostearate, white petrolatum.


Package Label.Principal Display Panel



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