GRANULOTION HEMORRHOIDAL- menthol, zinc oxide lotion 
GL Health, Inc.

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GRANULOTION Hemorrhoidal Lotion

DRUG FACTS

ACTIVE INGREDIENTS

Menthol 0.11%

Zinc Oxide 5.1%

PURPOSE

Analgesic, Anesthetic and Antipruritic

Astringent

USE

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

WARNINGS

For external use only

Keep out of reach of children.

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.

Package Labeling:

Label

GRANULOTION HEMORRHOIDAL 
menthol, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82897-293
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.1 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION51 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
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 ACETATE (UNII: 9E8X80D2L0)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82897-293-003.3 mL in 1 PACKET; Type 0: Not a Combination Product05/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01505/20/2022
Labeler - GL Health, Inc. (086010932)

Revised: 11/2023
Document Id: 09e37389-88c4-6f4c-e063-6394a90a9861
Set id: 1a32741c-5e4a-40e5-b15a-8233c5bdb92b
Version: 2
Effective Time: 20231111
 
GL Health, Inc.