Otc - Active Ingredient
Active ingredients
Diphenhydramine hydrochloride 2.0%
Menthol 1.0%
Tact Cream
FDA Label NDC 49873-705
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Inc., Ltd. for the product Tact (NDC 49873-705). 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, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Tactcreamcart.jpg
* Please review the disclaimer below.
