DG HEALTH COLD N HOT PAIN RELIEVING TOPICAL ANALGESIC- menthol, unspecified form liquid

DG Health Cold n Hot Pain Relieving by

Drug Labeling and Warnings

DG Health Cold n Hot 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 ingredients

Menthol 16%

Purpose

Topical analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with:

• ♦ simple backache
• ♦ arthritis
• ♦ strains
• ♦ bruises
• ♦ sprains

Warnings

For external use only. Test on a small patch of skin before applying generously.

When using this product

• ♦ use only as directed
• ♦ avoid contact with the eyes and mucous membranes
• ♦ do not apply to wounds or damaged skin
• ♦ do not bandage tightly
• ♦ do not use with heating pads or other heating devices
• ♦ if redness is present, discontinue use and consult a doctor
• ♦ if skin irritation occurs, discontinue use
• ♦ a transient burning sensation may occur upon application but generally disappears in several days

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 immediately.

Directions

adults and children 12 years of age and older:

• ♦ apply generously to affected area
• ♦ massage into painful area until thoroughly absorbed into skin
• ♦ repeat if necessary, but not more than 3 to 4 times daily
• ♦ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

Children 12 years or younger: ask a doctor

Other information

store at room temperature

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., capsaicin, citric acid, glycerin, isopropyl myristate, propylene glycol, water.

Questions or comments?

1-888-309-9030

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DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Carton

DG™ | health

Compare
to active
ingredient
of IcyHot®*

Cold'n Hot

Pain Relieving Liquid
Menthol 16%

• Powerful, fast and
  effective pain relief
• No-mess applicator
• Stain-free

2.5 FL OZ (74 mL)

INGREDIENTS AND APPEARANCE

DG HEALTH COLD N HOT PAIN RELIEVING  TOPICAL ANALGESIC
menthol, unspecified form liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-883
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	160 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Alcohol (UNII: 3K9958V90M)
Capsaicin (UNII: S07O44R1ZM)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-883-01	1 in 1 CARTON	12/27/2019
1		74 mL in 1 BOTTLE, WITH APPLICATOR; 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	12/27/2019

Labeler - Dolgencorp Inc (068331990)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(55910-883)