Tecnu Calagel

Tecnu Calagel
SPL v7
SPL
SPL Set ID 8bc9cbfe-1dd4-18ed-e053-2a95a90a7966
Route
TOPICAL
Published
Effective Date 2019-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (20 mg)
Inactive Ingredients
Polysorbate 20 Zinc Acetate Hypromellose 2208 (100 Mpa.s) Water Menthol, Unspecified Form Benzethonium Chloride Bisulfite Ion Edetic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-06-20 Until 2025-10-15

Description

Diphenhydramine HCL 2%


Medication Information

Warnings and Precautions

DO NOT USE:

•if allergic to sulfites •on children under 2 years of age unless directed by a doctor

•with any other products containing diphenydramine, even one taken by mouth

•on deep puncture wounds, animal bites or serious burns unless directed by a doctor

•on large areas of the body

Indications and Usage

for temporary relief of pain and itching associated with:

•minor burns •sunburn •minor cuts •scrapes •insect bites

•minor skin irritations

rashes due to: •poison oak •poison ivy •poison sumac

Dosage and Administration

Directions •do not use more often than directed

•adults and children 2 years of age and older

•cleanse skin with soap and warm water and dry affected area

•apply to affected area not more than 3 times daily

•may be covered with a sterile bandage, if bandaged, let dry first

•children under 2 years of age do not use, consult a doctor

Description

Diphenhydramine HCL 2%

Section 44425-7

Other Information Store at 59 to 86ºF (15 to 30ºC)

Section 50565-1

When using this product:

•KEEP OUT OF REACH OF CHILDREN

•if swallowed, get medical help or contact a poison control center right away

•avoid contact with eyes

Section 50566-9

Stop use and ask a doctor if: •condition worsens

•symptoms persist for more than 7 days or clear up and occur again within a few days

Section 50569-3

•on chicken pox •on measles

Section 51727-6

benzethonium chloride, disodium EDTA, fragrance, hypromellose,

menthol, polysorbate 20, purified water, sodium metabisulfite, zinc acetate

Section 51945-4

Section 53413-1

Questions? Call 1-800-482-4464

serious side effects may be reported to this number.

Section 55105-1

Purpose Topical analgesic / antihistamine

Section 55106-9

Diphenhydramine HCL 2%


Structured Label Content

Indications and Usage (34067-9)

for temporary relief of pain and itching associated with:

•minor burns •sunburn •minor cuts •scrapes •insect bites

•minor skin irritations

rashes due to: •poison oak •poison ivy •poison sumac

Dosage and Administration (34068-7)

Directions •do not use more often than directed

•adults and children 2 years of age and older

•cleanse skin with soap and warm water and dry affected area

•apply to affected area not more than 3 times daily

•may be covered with a sterile bandage, if bandaged, let dry first

•children under 2 years of age do not use, consult a doctor

Warnings and Precautions (34071-1)

DO NOT USE:

•if allergic to sulfites •on children under 2 years of age unless directed by a doctor

•with any other products containing diphenydramine, even one taken by mouth

•on deep puncture wounds, animal bites or serious burns unless directed by a doctor

•on large areas of the body

Section 44425-7 (44425-7)

Other Information Store at 59 to 86ºF (15 to 30ºC)

Section 50565-1 (50565-1)

When using this product:

•KEEP OUT OF REACH OF CHILDREN

•if swallowed, get medical help or contact a poison control center right away

•avoid contact with eyes

Section 50566-9 (50566-9)

Stop use and ask a doctor if: •condition worsens

•symptoms persist for more than 7 days or clear up and occur again within a few days

Section 50569-3 (50569-3)

•on chicken pox •on measles

Section 51727-6 (51727-6)

benzethonium chloride, disodium EDTA, fragrance, hypromellose,

menthol, polysorbate 20, purified water, sodium metabisulfite, zinc acetate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 1-800-482-4464

serious side effects may be reported to this number.

Section 55105-1 (55105-1)

Purpose Topical analgesic / antihistamine

Section 55106-9 (55106-9)

Diphenhydramine HCL 2%


Advanced Ingredient Data


Raw Label Data

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