MONS- glycerin, allantoin gel 
Pharmacal-International. Co., Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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MONS GEL

Active Ingredient                                       Purpose

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

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

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image description

MONS 
glycerin, allantoin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24765-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN8 g  in 100 g
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24765-125-011 in 1 BOX09/19/201907/31/2023
1150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/19/201907/31/2023
Labeler - Pharmacal-International. Co., Ltd (557805060)
Establishment
NameAddressID/FEIBusiness Operations
EcoWorldpharm Co., Ltd.688735061manufacture(24765-125)

Revised: 8/2023
 
Pharmacal-International. Co., Ltd