TECNU CALAGEL- diphenhydramine hydrochloride gel 
Tec Laboratories Inc.

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Diphenhydramine HCL 2%

Purpose Topical analgesic / antihistamine

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

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

•on chicken pox •on measles

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 and ask a doctor if: •condition worsens

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

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

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

benzethonium chloride, disodium EDTA, fragrance, hypromellose,

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

Questions? Call 1-800-482-4464

serious side effects may be reported to this number.

Calagel

Calagel POP

Calagel Dispenser

TECNU CALAGEL 
diphenhydramine hydrochloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51879-802
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51879-802-061 in 1 CARTON06/20/2019
1NDC:51879-802-66178.9 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51879-802-66178.9 g in 1 BOTTLE; Type 0: Not a Combination Product06/20/2019
3NDC:51879-802-44144 in 1 CARTON07/23/2019
3NDC:51879-802-161.86 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/20/2019
Labeler - Tec Laboratories Inc. (083647792)
Establishment
NameAddressID/FEIBusiness Operations
Tec Laboratories Inc.083647792manufacture(51879-802)

Revised: 10/2023
Document Id: 06c46c8c-7936-c44e-e063-6394a90a1d29
Set id: 8bc9cbfe-1dd4-18ed-e053-2a95a90a7966
Version: 4
Effective Time: 20231002
 
Tec Laboratories Inc.