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Over-the-counter medicine · no prescription needed

Diphenhydramine and levomenthol

Pain relief on the skin

Official FDA data, not advice

The label text is quoted exactly as the company filed it with the U.S. Food and Drug Administration (FDA), with a link to the official copy. The list of brands comes from the FDA NDC Directory.

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

If someone may have taken too much, call Poison Help: 1‑800‑222‑1222. In an emergency, call 911.

Quick answers

What is Diphenhydramine and levomenthol used for?
The Drug Facts label of Tact (Sato Pharmaceutical Inc., Ltd.) lists these uses: temporarily relieves pain and itching associated with; minor skin irritations; insect bites; minor cuts; scrapes; rashes due to poison ivy; sunburn; minor burns.
Do I need a prescription for Diphenhydramine and levomenthol?
No. The products on this page are sold without a prescription (over the counter).
Is a store brand the same as the name brand?
Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
Has Diphenhydramine and levomenthol been recalled?
No recall linked to these products appears in the FDA enforcement reports we use.

Drug Facts label

Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.

Tact · Sato Pharmaceutical Inc., Ltd.

Diphenhydramine hydrochloride 2% · Levomenthol 1%, cream (topical)

Active ingredient

Diphenhydramine hydrochloride 2.0% Menthol 1.0%

Purpose

P urpose Diphenhydramine Hydrochloride External analgesic l-Menthol External analgesic

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

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.

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 ingredients

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

— FDA label of Tact, Sato Pharmaceutical Inc., Ltd., effective December 4, 2023. See the official label on DailyMed →

Tact Cool Jelly · Sato Pharmaceutical Co., Ltd.

Diphenhydramine hydrochloride 2% · Levomenthol 1%, gel (topical)

Active ingredient

Diphenhydramine Hydrochloride 2.0% l-Menthol 1.0%

Purpose

Diphenhydramine Hydrochloride External analgesic l-Menthol External analgesic

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

For external use only

When using this product

  • avoid contact with the eyes

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.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

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 ingredients

I nactive ingredients alcohol, BHT, carboxyvinyl polymer, hydroxypropyl cellulose, monoethanolamine, nonoxynol 9, polysorbate 80, propylene glycol, purified water.

— FDA label of Tact Cool Jelly, Sato Pharmaceutical Co., Ltd., effective December 1, 2023. See the official label on DailyMed →

This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.

Same medicine, other brands

Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.

Diphenhydramine hydrochloride 2% · Levomenthol 1% · cream (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Tact Sato Pharmaceutical Inc., Ltd. DailyMed
Diphenhydramine hydrochloride 2% · Levomenthol 1% · gel (topical) · 1 product

Drug Facts for this strength and form ↑

Brand or product nameCompany on the labelLabel
Tact Cool Jelly Sato Pharmaceutical Co., Ltd. DailyMed

Companies that sell this medicine

The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.

  • Sato Pharmaceutical Inc., Ltd.1 product
  • Sato Pharmaceutical Co., Ltd.1 product

Recalls

No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. FDA rule for the Drug Facts label (21 CFR 201.66)

Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.

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