TECNU CALAGEL- diphenhydramine hydrochloride gel

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Hent Produktets egenskaber (SPC)
02-10-2023

Aktiv bestanddel:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Tilgængelig fra:

Tec Laboratories Inc.

Indgivelsesvej:

TOPICAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

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 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

Autorisation status:

OTC monograph not final

Produktets egenskaber

                                TECNU CALAGEL- DIPHENHYDRAMINE HYDROCHLORIDE GEL
TEC LABORATORIES INC.
----------
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.
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: 7T1F3
                                
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