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

DG Health Cold Zone Pain Relieving by

Drug Labeling and Warnings

DG Health Cold Zone Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Dolgencorp Inc, Garcoa, Inc., Sigan Industries INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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

• For arthritis, backache,
  muscle pain and joint pain
• Soothing Menthol
• Paraben free

2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-884
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
CARBOXYPOLYMETHYLENE (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
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-884-01	59 mL in 1 TUBE; Type 0: Not a Combination Product	03/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	03/05/2020

Labeler - Dolgencorp Inc (068331990)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(55910-884)