TACT
TACT is an FDA drug label for the active ingredient DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL manufactured by Sato Pharmaceutical Inc., Ltd. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231204.
- Generic name
- DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL
- Manufacturer
- Sato Pharmaceutical Inc., Ltd.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 49873-705
- Application
- M017
- Label effective
- 20231204
About this product
TACT is an FDA-registered drug product whose active ingredient is DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL. It is labelled by Sato Pharmaceutical Inc., Ltd. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 49873-705, application M017, label effective 20231204. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL are most often described in connection with: temporarily relieves, itching associated, minor skin, irritations insect, cuts scrapes, rashes due, poison ivy. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
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
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.
Warnings
Warnings For rectal use only When using this product ■ avoid contact with the eyes S top 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.
Recall and safety notices
5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0036-2026 | Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label). | Aspiro Pharma Limited | Class II | Ongoing | 20251029 |
| D-0441-2025 | BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31. | CareFusion 213, LLC | Class II | Ongoing | 20250528 |
| D-0040-2024 | Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979 | Imprimis NJOF, LLC | Class III | Terminated | 20231011 |
| D-1168-2023 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case). | CareFusion 213, LLC | Class II | Completed | 20230927 |
| D-0345-2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400 | CareFusion 213, LLC | Class I | Terminated | 20210505 |
Frequently asked questions
What is TACT used for?
Uses temporarily relieves pain and itching associated with ■ minor skin irritations ■ insect bites ■ minor cuts ■ scrapes ■ rashes due to poison ivy ■ sunburn ■ minor burns
Who makes TACT?
Sato Pharmaceutical Inc., Ltd. is the labeler of record for TACT.
What form does TACT come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is TACT prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has TACT been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.