DG HEALTH COLD ZONE PAIN RELIEVING  TOPICAL ANALGESIC- menthol, unspecified form gel 
Dolgencorp Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DG Health Cold Zone Pain Relieving Gel
Topical Analgesic

Drug Facts

Active ingredient

Menthol 4%

Purpose

Topical analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Warnings

For external use only

When using this product

avoid contact with eyes
do not apply to wounds or damaged skin
do not bandage tightly
do not use with heating pads or other heating devices

Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Flammable

keep away from fire or flame

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

adults and children 6 years of age and older apply to affected area not more than 3-4 times daily. Children under 6 years of age: Do Not Use.

Inactive ingredients

aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrtata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, sodium hydroxide, tocopheryl acetate, water, yellow 5.

Questions or comments?

1-888-309-9030

DISTRIBUTED BY
OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

PRINCIPAL DISPLAY PANEL - 59 mL Tube Label

DG™|health

Compare to
active
ingredient
of BIOFREEZE®
GEL*

Cold Zone
Pain Relieving
Gel

Topical Relief
Menthol 4% Topical Analgesic

2 FL OZ (59 mL)

PRINCIPAL DISPLAY PANEL - 59 mL Tube Label
DG HEALTH COLD ZONE PAIN RELIEVING   TOPICAL ANALGESIC
menthol, unspecified form gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-884
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Arnica Montana Flower (UNII: OZ0E5Y15PZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Glycerin (UNII: PDC6A3C0OX)  
Isopropyl Alcohol (UNII: ND2M416302)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Sodium Hydroxide (UNII: 55X04QC32I)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
Water (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-884-0159 mL in 1 TUBE; Type 0: Not a Combination Product03/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34803/05/2020
Labeler - Dolgencorp Inc (068331990)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan Industries INC.255106239MANUFACTURE(55910-884)

Revised: 1/2022
Document Id: a8ee8c27-f992-4c92-aa65-3435143faead
Set id: 22594ab8-9a4a-426f-aced-5c636620fa2c
Version: 2
Effective Time: 20220126
 
Dolgencorp Inc