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GranuLotion

Pure Source Inc

GranuLotion medicated lotion


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

GranuLotion medicated lotion


Active Ingredients

Menthol 0.11%

Zinc Oxide 5.1%

Purpose

External analgesic / Anti-itch

Skin protectant / Anorectal astringent

Uses:

Helps relieve the local itching and discomfort of the perianal area. Temporarily forms a protective barrier over inflamed tissues to help prevent the drying of tissues. For the temporary relief of pain, burning and skin irritation. Can help distract from pain and may provide a cooling sensation.

Warnings

For external use only * If condition worsens or does not improve within 7 days, consult a doctor * Do not exceed the recommended daily dose unless directed by a doctor * In case of bleeding consult a doctor promptly * Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.


Directions:

When practical, cleanse the affected area with mild soap and warm water. Pat or allow to air dry. Apply a layer of GranuLotion® up to 6 times daily for inflammation, 1 time per day for continued site maintenance. Use a soft tipped applicator for hard to reach areas. Repeat as needed to protect the skin or until the condition resolves.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Betaglucans, Cetearly Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycrrhiza Glabra (Licorice Extract, Helianthus Annuus (Sunflower) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Olea Europaea (Olive) Oil, PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Potassium Alum, Tocopheryl Acetate (Vitamin E), FDandC Blue 1.

GranuLotion medicated lotion 1oz/28.349g (65121-885-23)

GranuLotion
GranuLotion

GranuLotion

MENTHOL, ZINC OXIDE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65121-885
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 0.11 g
Zinc Oxide Zinc oxide 5.1 g

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
water
CETOSTEARYL ALCOHOL
ETHYLHEXYLGLYCERIN
GLYCERIN
GLYCERYL MONOSTEARATE
LICORICE
SUNFLOWER OIL
TEA TREE OIL
olive oil
PEG-100 STEARATE
PHENOXYETHANOL
POLYSORBATE 20
POTASSIUM ALUM
.ALPHA.-TOCOPHEROL
FD&C BLUE NO. 1

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28.349 in 1 BOTTLE
2 NDC:65121-885-23 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part346 2014-03-26


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Be sure to consult your doctor before taking any medication!
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