Otc - Active Ingredient
Active ingredients
Diphenhydramine Hydrochloride 2.0%
l-Menthol 1.0%
Tact Cool Gel
FDA Label NDC 49873-704
10 label sections · Submitted to the FDA by Sato Pharmaceutical Co., Ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Tact Cool (NDC 49873-704). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
I nactive 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
tactcjcart.jpg
Carton (Tactcjcart)
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