TECNU CALAGEL- diphenhydramine hydrochloride, zinc acetate gel 
Tec Laboratories Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Diphenhydramine HCL 2%

Zinc acetate 0.215

Purpose Topical analgesic / antihistamine- Skin protectant

for temporary relief of pain and itching associated with:

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

•minor skin irritations •poison oak •poison ivy •poison sumac

dries oozing and weeping of poison: •ivy •oak •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 InformationStore at 59 tp 86ºF (15 to 30ºC)

benzethonium chlori de, disodium EDTA, fragrance, hypromellose,

menthol, polysorbate 20, purified water, sodium metabisulfite

Questions? Call 1-800-482-4464

serious side effects may be reported to this number.

Calagel Label

Calagel POP

TECNU CALAGEL 
diphenhydramine hydrochloride, zinc acetate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51879-801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE2.15 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51879-801-061 in 1 CARTON10/03/2018
1NDC:51879-801-66178.9 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51879-801-44144 in 1 CARTON10/03/2018
2NDC:51879-801-161.86 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/03/201803/26/2019
Labeler - Tec Laboratories Inc. (083647792)
Establishment
NameAddressID/FEIBusiness Operations
Tec Laboratories Inc.083647792manufacture(51879-801)

Revised: 3/2019
 
Tec Laboratories Inc.