MONS- glycerin, allantoin gel

MONS by

Drug Labeling and Warnings

MONS by is a Otc medication manufactured, distributed, or labeled by Pharmacal-International. Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient                                       Purpose

GLYCERIN 8.0%------------------------- Skin protectant
ALLANTOIN 0.1%-----------------------  Skin protectant

PURPOSE

Indication and Usage

Apply the appropriate amount before and after exercising,
as if you are gently massaging your hands or vibration applications, on the areas you need,
except your face.

Dosage and Administration

Apply liberally as needed, softly massage for absorption

Warnings

■ Do not use on dermatitis, damaged skin or eczema
■ Stop using and ask a doctor if rash, swelling, or irritation occurs
■ Keep out of reach of children
■ Follow the directions

Inactive ingrdients

WATER,CAPRYLIC/CAPRIC TRIGLYCERIDE,POLYSORBATE 80,VANILLYL BUTYL,ETHER,ALCOHOL,BUTYLENE,GLYCOL,CARBOMER,TRIETHANOLAMINE,MENTHOL,ETHYLHEXYLGLYCERIN,CAPRYLYLGLYCOL,PROPYLENE,GLYCOL,POLYACRYLAMIDE,1,2-HEXANEDIOL,DIMETHYL SULFONE,ACETYL GLUCOSAMINE,C13-14 ISOPARAFFIN,TROPOLONE,PHOENIX DACTYLIFERA (DATE) FRUIT EXTRACT,FICUS CARICA (FIG) FRUIT EXTRACT,LAURETH-7,HYDROXYACETOPHENONE,CAPSICUM FRUTESCENS FRUIT EXTRACT,CENTELLA ASIATICA EXTRACT,OPUNTIA FICUS-INDICA EXTRACT,OPUNTIA COCCINELLIFERA FRUIT EXTRACT,ADANSONIA DIGITATA SEED EXTRACT,SCUTELLARIA BAICALENSIS ROOT EXTRACT,POLYGONUM CUSPIDATUM ROOT EXTRACT,SODIUM HYALURONATE,GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT,CAMELLIA SINENSIS LEAF EXTRACT,ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT,CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT,PERILLA OCYMOIDES LEAF EXTRACT,ACORUS CALAMUS ROOT EXTRACT,DISODIUM EDTA,FRAGRANCE,BENZYL BENZOATE,CITRONELLOL,GERANIOL.

Principal Display Panel

INGREDIENTS AND APPEARANCE

MONS 
glycerin, allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24765-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	8 g  in 100 g
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
TROPOLONE (UNII: 7L6DL16P1T)
FIG (UNII: TGD87RII2U)
LAURETH-7 (UNII: Z95S6G8201)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
TABASCO PEPPER (UNII: J1M3NA843L)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
ADANSONIA DIGITATA SEED (UNII: 2936P60TPX)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ROSEMARY (UNII: IJ67X351P9)
CHAMOMILE (UNII: FGL3685T2X)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BENZYL BENZOATE (UNII: N863NB338G)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24765-125-01	1 in 1 BOX	09/19/2019
1		150 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/19/2019

Labeler - Pharmacal-International. Co., Ltd (557805060)

Establishment
Name	Address	ID/FEI	Business Operations
GreenCos Co., Ltd.		694777325	manufacture(24765-125)