TECNU CALAGEL- diphenhydramine hydrochloride gel

Tecnu Calagel by

Drug Labeling and Warnings

Tecnu Calagel by is a Otc medication manufactured, distributed, or labeled by Tec Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Diphenhydramine HCL 2%

PURPOSE

Purpose Topical analgesic / antihistamine

INDICATIONS & 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

WARNINGS

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

ASK DOCTOR

on chicken pox on measles

KEEP OUT OF REACH OF CHILDREN

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

STOP USE

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

DOSAGE & 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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

benzethonium chloride, disodium EDTA, fragrance, hypromellose,

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

QUESTIONS

Questions? Call 1-800-482-4464

serious side effects may be reported to this number.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TECNU CALAGEL 
diphenhydramine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51879-802
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ZINC ACETATE (UNII: FM5526K07A)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
WATER (UNII: 059QF0KO0R)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51879-802-06	1 in 1 CARTON	06/20/2019
1	NDC: 51879-802-66	178.9 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 51879-802-66	178.9 g in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2019
3	NDC: 51879-802-44	144 in 1 CARTON	07/23/2019
3	NDC: 51879-802-16	1.86 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/20/2019

Labeler - Tec Laboratories Inc. (083647792)

Establishment
Name	Address	ID/FEI	Business Operations
Tec Laboratories Inc.		083647792	manufacture(51879-802)