GRANULOTION - menthol and zinc oxide lotion 
Pure Source Inc

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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GranuLotion medicated lotion

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)

GranuLotionA

GranuLotionB

GRANULOTION 
menthol, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65121-885
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL0.11 g  in 100 g
ZINC OXIDE (ZINC CATION) ZINC CATION5.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65121-885-231 in 1 BOX
128.349 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34603/26/2014
Labeler - Pure Source Inc (969241041)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source Inc969241041manufacture(65121-885)

Revised: 3/2014
Document Id: 430b3001-dae7-4a7b-be89-0f3f17ddf262
Set id: 81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3
Version: 1
Effective Time: 20140326
 
Pure Source Inc