Tact Cream

Tact Cream
SPL v4
SPL
SPL Set ID b6e2ee24-69de-4dfd-9081-b9537b7a7bad
Route
TOPICAL
Published
Effective Date 2012-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (2 g) Levomenthol (1 g)
Inactive Ingredients
Diethanolamine Edetate Sodium Light Mineral Oil Peg-40 Stearate Propylene Glycol Propylparaben Water Sorbitan Monostearate Petrolatum Butylparaben Carbomer Homopolymer Type C Cetyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1997-09-09

Description

Active ingredients    Diphenhydramine hydrochloride 2.0% Menthol 1.0%


Medication Information

Warnings and Precautions

Warnings

For rectal use only

Indications and 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



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% 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 50566-9

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.

Section 50567-7

When using this product



■ avoid contact with the eyes

Section 51727-6

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.

Section 51945-4



tactcreamcart.jpg

Section 55105-1

P urpose   

Diphenhydramine Hydrochloride    External analgesic

l-Menthol    External analgesic

Section 55106-9

Active ingredients  

Diphenhydramine hydrochloride 2.0%

Menthol 1.0%


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves pain and itching associated with

■ minor skin irritations    ■ insect bites    ■ 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 rectal 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 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product



■ avoid contact with the eyes

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)



tactcreamcart.jpg

Section 55105-1 (55105-1)

P urpose   

Diphenhydramine Hydrochloride    External analgesic

l-Menthol    External analgesic

Section 55106-9 (55106-9)

Active ingredients  

Diphenhydramine hydrochloride 2.0%

Menthol 1.0%


Advanced Ingredient Data


Raw Label Data

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