THE ITCH ERASER- diphenhydramine hydrochloride spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Adventure Ready Brands

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical analgesic ​For temporary relief of pain and itching associated with: ​ • minor burns • sunburn • minor cuts • insect bites • minor skin irritations • rashes due to poison ivy, poison oak, and poison sumac • on large areas of the body • with any other product containing diphenhydramine, even one taken by mouth • on chicken pox • on measles • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days

Authorization status:

OTC monograph not final

Summary of Product characteristics

THE ITCH ERASER- DIPHENHYDRAMINE HYDROCHLORIDE SPRAY
ADVENTURE READY BRANDS
_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._
----------
THE ITCH ERASER SPRAY
_​DRUG FACTS_
_​ACTIVE INGREDIENTS:_
Diphenhydramine HCl 2%
_​PURPOSE:_
Topical analgesic
_​USES_
​FOR TEMPORARY RELIEF OF PAIN AND ITCHING ASSOCIATED WITH:​
• minor burns
• sunburn
• minor cuts
• insect bites
• minor skin irritations
• rashes due to poison ivy, poison oak, and poison sumac
_​WARNINGS_
​FOR EXTERNAL USE ONLY​
​
DO NOT USE
• on large areas of the body
• with any other product containing diphenhydramine, even one taken
by mouth
ASK A DOCTOR BEFORE USE
• on chicken pox • on measles
WHEN USING THIS PRODUCT
avoid contact with the eyes.
STOP USE AND ASK A DOCTOR IF
• condition worsens • symptoms last more than 7 days or clear up
and occur again
within a few days
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_​DIRECTIONS_
​DO NOT USE MORE OFTEN THAN DIRECTED
ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: ​
apply to affected area not more
than 3 to 4 times daily.
CHILDREN UNDER 2 YEARS OF AGE​: ask a doctor.
_​INACTIVE INGREDIENTS_
Glycerin, Oat Beta Glucan, Povidone, Purified Water, SD Alcohol 40-2,
Sodium
Bicarbonate (Baking Soda), Tea Tree Oil, Vitamin E Acetate, Zinc
Acetate
PACKAGE LABELING
THE ITCH ERASER
diphenhydramine hydrochloride spray
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:90107-2410
ROUTE OF ADMINISTRATION
TOPICAL
Adventure Ready Brands
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
(DIPHENHYDRAMINE - UNII:8GTS82S83M)
DIPHENHYDRAMINE
HYDROCHLORIDE
20 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
OAT (UNII: Z6J799EAJK)
ALCOHOL (UNII: 3K9958V90M)
WA