MONS- glycerin, allantoin gel

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX), ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)
Available from:
Pharmacal-International. Co., Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
GLYCERIN 8.0%------------------------- Skin protectant ALLANTOIN 0.1%-----------------------  Skin protectant
Authorization status:
unapproved drug other
Authorization number:
24765-125-01

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.

----------

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

MONS

glycerin, allantoin gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:2476 5-125

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX) (GLYCERIN - UNII:PDC6 A3C0 OX)

GLYCERIN

8 g in 10 0 g

ALLANTO IN (UNII: 344S277G0 Z) (ALLANTOIN - UNII:344S277G0 Z)

ALLANTOIN

.1 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

VANILLYL BUTYL ETHER (UNII: S2ULN37C9 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PO LYACRYLAMIDE ( CRO SSLINKED; 2 MO LE PERCENT BISACRYLAMIDE) (UNII: 9 FPL31B58 Q)

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT)

N-ACETYLGLUCO SAMINE (UNII: V9 56 6 9 6 549 )

C13 -14 ISO PARAFFIN (UNII: E4F12ROE70 )

TRO PO LO NE (UNII: 7L6 DL16 P1T)

FIG (UNII: TGD8 7RII2U)

LAURETH-7 (UNII: Z9 5S6 G8 20 1)

HYDRO XYACETO PHENO NE (UNII: G1L3HT4CMH)

TABASCO PEPPER (UNII: J1M3NA8 43L)

CENTELLA ASIATICA (UNII: 7M8 6 7G6 T1U)

O PUNTIA FICUS-INDICA (UNII: 23Z8 7HTQ6 P)

O PUNTIA CO CHENILLIFERA FRUIT (UNII: 8 38 ZTK0 2KH)

ADANSO NIA DIGITATA SEED (UNII: 29 36 P6 0 TPX)

SCUTELLARIA BAICALENSIS RO O T (UNII: 7J9 5K7ID2S)

REYNO UTRIA JAPO NICA RO O T (UNII: 7TRV45YZF7)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

GLYCYRRHIZA GLABRA (UNII: 278 8 Z9 758 H)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

RO SEMARY (UNII: IJ6 7X351P9 )

CHAMO MILE (UNII: FGL36 8 5T2X)

PERILLA FRUTESCENS LEAF (UNII: T4L58 8 1Y6 8 )

ACO RUS CALAMUS RO O T (UNII: XY1K7KIQ0 F)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

BENZYL BENZO ATE (UNII: N8 6 3NB338 G)

.BETA.-CITRO NELLO L, ( +/-) - (UNII: 56 5OK72VNF)

GERANIO L (UNII: L8 3710 8 USY)

Packag ing

Pharmacal-International. Co., Ltd

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:2476 5-125-0 1

1 in 1 BOX

0 9 /19 /20 19

1

150 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 9 /19 /20 19

Labeler -

Pharmacal-International. Co., Ltd (557805060)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

GreenCo s Co ., Ltd.

6 9 4777325

ma nufa c ture (2476 5-125)

Revised: 9/2019

Similar products

Search alerts related to this product

View documents history

Share this information