GRANULOTION- menthol, zinc oxide lotion 
Pure Source, LLC

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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 DRUGItem Code (Source)NDC:65121-885
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.11 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POTASSIUM ALUM (UNII: 1L24V9R23S)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LICORICE (UNII: 61ZBX54883)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65121-885-231 in 1 BOX02/09/2017
128.349 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01503/26/2014
Labeler - Pure Source, LLC (080354456)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(65121-885)

Revised: 11/2023
Document Id: 09d7554e-9396-9886-e063-6394a90a1a85
Set id: 81b70fd5-2fc0-4962-b9a0-ff0c961dd9e3
Version: 4
Effective Time: 20231110
 
Pure Source, LLC