HISTAMINE DHCL 0.10 PERCENT AND MENTHOL 2 PERCENT- histamine dihydrochloride and menthol spray

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)

MAH:

7T Pharma LLC

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

Topical analgesic Topical analgesic For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

authorization_status:

OTC monograph not final

SPC

HISTAMINE DHCL 0.10 PERCENT AND MENTHOL 2 PERCENT- HISTAMINE
DIHYDROCHLORIDE
AND MENTHOL SPRAY
7T PHARMA LLC
_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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HISTAMINE DHCL AND MENTHOL TOPICAL SPRAY
HISTAMINE AND MENTHOL - HISTAMINE DHCL 0.10% AND MENTHOL 2% TOPICAL
SPRAY
7T PHARMA, LLC
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HISTAMINE DHCL 0.10% AND MENTHOL 2% TOPICAL SPRAY
DRUG FACTS
ACTIVE INGREDIENT
Histamine Dihydrochloride 0.10%
Menthol 2%
PURPOS E
Topical analgesic
Topical analgesic
US ES
For the temporary relief of minor aches and pains of muscles and
joints, such as simple backache,
lumbago, arthritis, neuralgia, strains, bruises, and sprains.
WARNINGS
FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT
do not use in or near the eyes
do not use in large quantities, particularly over raw surfaces or
blistered areas
STOP USE AND ASK A DOCTOR IF
allergic reaction occurs
condition worsens or does not improve within 7 days
symptoms clear up and return within a few days
redness, irritation, swelling, pain or other symptoms begin or
increase
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
adults and children 2 years
and older
apply externally to the affected area up to 3 to
4 times a day
children under 2 years
ask a doctor
OTHER INFORMATION
May be applied under occlusive dressing.
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C
(59-86°F). See USP Controlled
Room Temperature.
INACTIVE INGREDIENTS
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),
Arnica Montana
Flower Extract, Boswellia Serrata Extract, Cetyl Myristoleate,
Ethylhexylglycerin, Glycyrrhiza Glabra
(Licorice) Extract, Ilex Paraguaiensis (Yerba Mate) Extract, Magnesium
Sulfate, Methylsulfonylmethane
(MSM), Polysorbate-20, SD-Alcohol 40B, Phenoxyethanol
HISTAMINE DHCL 0.10% AND MENTHOL 2% TOPICAL SPRAY
NDC 70645-2