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TACT

Sato Pharmaceutical Inc., Ltd.

DRUG FACTS




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients  
Diphenhydramine hydrochloride 2.0%
Menthol 1.0%

Purpose

P urpose   
Diphenhydramine Hydrochloride    External analgesic
l-Menthol    External analgesic

Uses

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.



TACT



TACT

TACT

diphenhydramine hydrochloride, menthol CREAM

Product Information

Product Type Human otc drug label 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 2 g
LEVOMENTHOL 1 g

Inactive Ingredients

Ingredient Name Strength
BUTYLPARABEN
CARBOMER HOMOPOLYMER TYPE C
CETYL ALCOHOL
DIETHANOLAMINE
EDETATE SODIUM
LIGHT MINERAL OIL
PEG-40 STEARATE
propylene glycol
PROPYLPARABEN
water
SORBITAN MONOSTEARATE
petrolatum

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 20 in 1 TUBE
2 NDC:49873-705-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 1997-09-09


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Be sure to consult your doctor before taking any medication!
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