FDA Label for Tact Cool Jelly
View Indications, Usage & Precautions
Tact Cool Jelly Product Label
The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., 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%
l-Menthol 1.0%
Indications & Usage
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
Warnings
For external use only
Otc - When Using
When using this product
■avoid contact with the eyes
Otc - Ask Doctor
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 alcohol, BHT, carboxyvinyl polymer, hydroxypropyl cellulose, monoethanolamine, nonoxynol 9, polysorbate 80, propylene glycol, purified water.
Otc - Purpose
Diphenhydramine Hydrochloride External analgesic
l-Menthol External analgesic
Package Label.Principal Display Panel
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