Tact Cool Jelly

Tact Cool Jelly
SPL v7
SPL
SPL Set ID f34872c9-91b9-49db-8e41-5b54a069284a
Route
TOPICAL
Published
Effective Date 2011-12-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (2 g) Levomenthol (1 g)
Inactive Ingredients
Alcohol Butylated Hydroxytoluene Carbomer Homopolymer Type C Hydroxypropyl Cellulose Monoethanolamine Nonoxynol-9 Polysorbate 80 Propylene Glycol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1997-10-02

Description

Active ingredients Diphenhydramine Hydrochloride 2.0%    l-Menthol 1.0%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

temporarily relieves pain and itching associated with

■insect bites    ■minor skin irritations    ■minor cuts

■scrapes    ■rashes due to poison ivy    ■sunburn    ■minor burns

Dosage and 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.



Description

Active ingredients Diphenhydramine Hydrochloride 2.0%    l-Menthol 1.0%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product



■avoid contact with the eyes

Section 50569-3

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.





Section 51727-6

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

Section 51945-4

tactcjcart.jpg

Section 55105-1

Diphenhydramine Hydrochloride     External analgesic

l-Menthol                                             External analgesic

Section 55106-9

Active ingredients



Diphenhydramine Hydrochloride 2.0%   

l-Menthol 1.0%




Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves pain and itching associated with

■insect bites    ■minor skin irritations    ■minor cuts

■scrapes    ■rashes due to poison ivy    ■sunburn    ■minor burns

Dosage and Administration (34068-7)

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.



Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product



■avoid contact with the eyes

Section 50569-3 (50569-3)

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.





Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

tactcjcart.jpg

Section 55105-1 (55105-1)

Diphenhydramine Hydrochloride     External analgesic

l-Menthol                                             External analgesic

Section 55106-9 (55106-9)

Active ingredients



Diphenhydramine Hydrochloride 2.0%   

l-Menthol 1.0%




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)