TACT- diphenhydramine hydrochloride, menthol cream

TACT by

Drug Labeling and Warnings

TACT by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Inc., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients  
Diphenhydramine hydrochloride 2.0%
Menthol 1.0%

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

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.

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.

PRINCIPAL DISPLAY PANEL

tactcreamcart.jpg

INGREDIENTS AND APPEARANCE

TACT 
diphenhydramine hydrochloride, menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-705
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g  in 100 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIETHANOLAMINE (UNII: AZE05TDV2V)
EDETATE SODIUM (UNII: MP1J8420LU)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PEG-40 STEARATE (UNII: ECU18C66Q7)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-705-01	1 in 1 CARTON	09/09/1997
1		20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/09/1997

Labeler - Sato Pharmaceutical Inc., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Inc., Ltd.		715699133	manufacture(49873-705) , label(49873-705) , pack(49873-705)