TECNU CALAGEL- diphenydramine hydrochloride, zinc acetate, benzethonium chloride 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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Active Ingredient

Benzethonium chloride 0.15%

Diphenhydramine HCl 2%

Zinc acetate 0.215%

Purpose

First aid antiseptic

Topical analgesic / antihistamine

Skin protectant

Uses

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

Warnings

For external use only

Do not use:

  • If allergic to sulfites
  • On children under 2 years of age unless directed by a doctor
  • With any other product containing diphenhydramine, 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 a doctor before use:​

  • On chicken pox
  • On measles

When using this product:​

  • KEEP OUT OF REACH OF CHILDREN
  • If swallowed, get medical help or contact a posion 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 convered with a sterile bandage; if bandage, let dry first
  • Children under 2 years of age:do not use, consult a doctor

Other Information​

Store at 59 to 86º​F (15 to 30ºC)

Inactive Ingredients

disodium EDTA, fragrance, hypromellose, menthol, polysorbate 20, purified water, and sodium metabisulfite

Questions?

Call 1-800-482-4464. Serious side effects may be reported to this number.

Calagel 6 oz. Bottle Outer Carton

OUTDOOR SOLUTIONS SINCE 1962

tecnu

First Aid Antiseptic, Skin Protectant & Topical Analgesic

NDC 51879-800-06

CALAGEL

Relieves Itch and Pain

Maximum Strength Anti-Itch

Poison Oak & Poison Ivy

Insect Bites

Sunburns and more!

Includes travel size Tecnu Original

CALAGEL

6 FL OZ

(177.4 ml)

Tecnu Original

2 FL OZ.

(59.2 ml)

Calagel 6 oz. Outer Carton

Calagel Packet Outer Carton

OUTDOOR SOLUTIONS SINCE 1962

tecnu

First Aid Antiseptic, Skin Protectant & Topical Analgesic

Relieves Itch and Pain

Skin Protectant

Topical Analgesic

First Aid Antiseptic Gel

144 PACKETS

NET 1/16 FL. OZ.

(1.84 ML) PER PACKET

Calagel Packet Dispenser Carton Label

TECNU CALAGEL 
diphenydramine hydrochloride, zinc acetate, benzethonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51879-800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1.5 mg  in 1 g
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
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MENTHOL (UNII: L7T10EIP3A)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51879-800-061 in 1 CARTON10/09/199210/02/2018
1NDC:51879-800-66178.9 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51879-800-44144 in 1 CARTON10/09/199210/02/2018
2NDC:51879-800-161.86 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 finalpart34810/09/199210/02/2018
Labeler - Tec Laboratories, Inc. (083647792)
Establishment
NameAddressID/FEIBusiness Operations
Tec Laboratories, Inc.083647792manufacture(51879-800)

Revised: 2/2019
 
Tec Laboratories, Inc.