Tact Cool Jelly: Package Insert and Label Information

TACT COOL JELLY- diphenhydramine hydrochloride and levomenthol gel
Sato Pharmaceutical Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredients

Diphenhydramine Hydrochloride 2.0%
l-Menthol 1.0%

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.

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

Diphenhydramine Hydrochloride External analgesic
l-Menthol External analgesic

tactcjcart.jpg

Carton
(click image for full-size original)

TACT COOL JELLY
diphenhydramine hydrochloride, levomenthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-704
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
ALCOHOL
BUTYLATED HYDROXYTOLUENE
CARBOMER HOMOPOLYMER TYPE C
HYDROXYPROPYL CELLULOSE
MONOETHANOLAMINE
NONOXYNOL-9
POLYSORBATE 80
PROPYLENE GLYCOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49873-704-01 1 TUBE in 1 CARTON contains a TUBE
1 20 g in 1 TUBE This package is contained within the CARTON (49873-704-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 10/02/1997
Labeler — Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
Name Address ID/FEI Operations
Sato Pharmaceutical Co., Ltd. 715699133 manufacture (49873-704), label (49873-704), pack (49873-704)

Revised: 09/2019 Sato Pharmaceutical Co., Ltd.

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