OTC Medication Information: TACT

TACT- diphenhydramine hydrochloride and levomenthol cream
Sato Pharmaceutical Inc., Ltd.

Active ingredients
Diphenhydramine hydrochloride 2.0%
Menthol 1.0%

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.


tactcreamcart.jpg

carton
(click image for full-size original)

TACT
diphenhydramine hydrochloride, menthol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-705
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 2 g in 100 g
LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
DIETHANOLAMINE
EDETATE SODIUM
LIGHT MINERAL OIL
PEG-40 STEARATE
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SORBITAN MONOSTEARATE
PETROLATUM
BUTYLPARABEN
CARBOMER HOMOPOLYMER TYPE C
CETYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49873-705-01 1 TUBE in 1 CARTON contains a TUBE
1 20 g in 1 TUBE This package is contained within the CARTON (49873-705-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 09/09/1997
Labeler — Sato Pharmaceutical Inc., Ltd. (690575642)
Establishment
Name Address ID/FEI Operations
Sato Pharmaceutical Inc., Ltd. 715699133 manufacture (49873-705), label (49873-705), pack (49873-705)

Revised: 12/2023 Sato Pharmaceutical Inc., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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