MANCORE MUSCLE MEND ROLL-ON PAIN RELIEVER- histamine dihydrochloride lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)

Available from:

R2 Distribution, LLC

INN (International Name):

HISTAMINE DIHYDROCHLORIDE

Composition:

HISTAMINE DIHYDROCHLORIDE 0.6 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

For temporary relief of minor aches and pains of muscles and joints associated with arthritis, backache and sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

MANCORE MUSCLE MEND ROLL-ON PAIN RELIEVER - HISTAMINE DIHYDROCHLORIDE
LOTION
R2 DISTRIBUTION, 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._
----------
MANCORE MUSCLE MEND ROLL-ON PAIN RELIEVER
MANCORE MUSCLE MEND ROLL-ON PAIN RELIEVER
ACTIVE INGREDIENT / PURPOSE
Histamine DHCl 0.06% / External Analgesic
US ES
For temporary relief of minor aches and pains of muscles and joints
associated with arthritis, backache
and sprains
WARNINGS
Use only as directed. For external use only. Not intended for persons
under the age 18.
WHEN USING THIS PRODUCT:
Avoid contact with eyes
Do not bandage tightly
Do not apply to open wounds or damaged skin
STOP USE AND ASK A DOCTOR IF:
symptoms persist for more than seven days
you experience irritation, redness or discomfort
DIRECTIONS :
Apply directly to effected area. Do not use more than four times per
day.
OTHER INFORMATION:
Do not use if tamper resistant seal is broken. Store in a cool, dry
place and avoid excessive heat or
cold.
Keep out of reach of children.
INACTIVE INGREDIENTS:
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),
Arnica Montana Flower
Extract, Boswellia Serrata Extract, Cetearyl Olivate, Cocos Nucifera
(Coconut) Oil, Eucalyptus
Globulus Oil, Gluconolactone, Glycerin, Methylsulfonylmethane (MSM),
Salix Alba (Willow Bark)
Extract, Sodium Benzoate, Sodium Hydroxide, Sorbitan Olivate, Xanthan
Gum, Zemea (Corn)
Propanediol
MANCORE MUSCLE MEND ROLL-ON PAIN RELIEVER 3OZ (69198-700-85)
MANCORE MUSCLE MEND ROLL-ON PAIN RELIEVER
histamine dihydrochloride lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 19 8 -70 0
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
HISTAMINE DIHYDRO CHLO RIDE (UNII: 3POA0 Q6 44U) (HISTAMINE -
UNII:8 20 48 4N8 I3)
HISTAMINE
DIHYDROCHLORIDE
0 .6 mg
in 1 mL
INACTIVE INGRED