DR VAROGEL- glycerin, allantoin gel

DR VAROGEL by

Drug Labeling and Warnings

DR VAROGEL 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 10%------------------------- 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, 1,2-HEXANEDIOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYSORBATE 80, VANILLYL BUTYL ETHER, ALCOHOL,
BUTYLENE GLYCOL, FRAGRANCE, TRIETHANOLAMINE, CARBOMER, PROPYLENE GLYCOL, MENTHOL, POLYACRYLAMIDE,
CAMPHOR, ACETYL GLUCOSAMINE, DIMETHYL SULFONE, C13-14 ISOPARAFFIN, ETHYLHEXYLGLYCERIN, PHOENIX
DACTYLIFERA (DATE) FRUIT EXTRACT, FICUS CARICA (FIG) FRUIT EXTRACT, CAPSICUM FRUTESCENS FRUIT EXTRACT, DISODIUM
EDTA, LAURETH-7, CENTELLA ASIATICA EXTRACT, OPUNTIA FICUS-INDICA STEM EXTRACT, OPUNTIA COCCINELLIFERA FRUIT
EXTRACT, ADANSONIA DIGITATA SEED EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, POLYGONUM CUSPIDATUM ROOT
EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, SODIUM HYALURONATE, CAMELLIA SINENSIS LEAF EXTRACT,
REHMANNIA GLUTINOSA ROOT EXTRACT, PORIA COCOS EXTRACT, PANAX GINSENG ROOT EXTRACT, PAEONIA ALBIFLORA ROOT
EXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, CINNAMOMUM CASSIA BARK EXTRACT, ATRACTYLODES JAPONICA RHIZOME
EXTRACT, ASTRAGALUS MEMBRANACEUS ROOT EXTRACT, ANGELICA GIGAS ROOT EXTRACT, ROSMARINUS OFFICINALIS
(ROSEMARY) LEAF EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, BENZYL BENZOATE, CITRONELLOL, GERANIOL

Principal Display Panel

INGREDIENTS AND APPEARANCE

DR VAROGEL 
glycerin, allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24765-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	10 g  in 100 g
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.1 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)
LEVOMENTHOL (UNII: BZ1R15MTK7)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DATE (UNII: H3O7QI5HY7)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
N-ACETYL-.ALPHA.-D-GLUCOSAMINE (UNII: T13TI5GH3D)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
FIG (UNII: TGD87RII2U)
LAURETH-7 (UNII: Z95S6G8201)
TABASCO PEPPER (UNII: J1M3NA843L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)
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)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
FU LING (UNII: XH37TWY5O4)
ASIAN GINSENG (UNII: CUQ3A77YXI)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)
CHINESE CINNAMON (UNII: WS4CQ062KM)
ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O)
ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF)
ANGELICA GIGAS ROOT (UNII: 32766B2FHX)
ROSEMARY (UNII: IJ67X351P9)
CHAMOMILE (UNII: FGL3685T2X)
BENZYL BENZOATE (UNII: N863NB338G)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24765-126-01	1 in 1 BOX	02/21/2020
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
OTC monograph not final	part348	02/21/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
GreenCos Co., Ltd.		694777325	manufacture(24765-126)