COLD ZONE PAIN RELIEVING GEL- DG HEALTH- menthol gel

Cold Zone Pain Relieving Gel- DG Health by

Drug Labeling and Warnings

Cold Zone Pain Relieving Gel- DG Health by is a Otc medication manufactured, distributed, or labeled by Velocity Pharma LLC, Yash Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Menthol USP 4%

Purpose

Cooling Pain Relief

Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: - arthritis - backache - strains - sprains

Warnings:

For external use only

Flammable:

Keep away from excessive heat or open flame.

Ask a doctor before use if you have:

sensitive skin

When using this product:

• Avoid contact with the eyes or mucous membranes
• Do not apply to wounds or damaged skin
• Do not use with other ointments, creams, sprays or liniments
  
• Do not apply to irritated skin or if excessive irritated develops
  
• Do not bandage
  
• Wash hands after use with cool water
• Do not use with heating pad or device
  

Stop use and ask a doctor if:

Condition worsens, or if symptoms  persist for more than 7 days, or clear up and recur

If pregnant or breast-feeding:

Ask a health professional before use

Keep out of reach of children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions:

• Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
• Children under 2 years of age: Consult physician
  

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients

Purified water, Glycerin, Isopropyl alcohol, Iso propyl myristate, Carbopol usp, Aloevera gel, Arnica montana flower extract, Articum lappa root (burdock) extract, Boswellia carterii resin extract, Calendula officinalis extract, Camellia sinensis leaf extract, Iiex paraguariensis leaf extract, Melissa officinalis (lemon balm) leaf extract, Tocopheryl acetate, Triethanolamine, Colloidal silicon dioxide, Sorbic acid, Camphor, Brillient blue, Tartrazin supra

Cold Zone Pain Relieving Gel- DG Health

INGREDIENTS AND APPEARANCE

COLD ZONE PAIN RELIEVING GEL- DG HEALTH 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76168-401
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
BRILLIANT BLUE G (UNII: M1ZRX790SI)
PETROLATUM (UNII: 4T6H12BN9U)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
FRANKINCENSE (UNII: R9XLF1R1WM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TROLAMINE (UNII: 9O3K93S3TK)
SORBIC ACID (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76168-401-41	59.14 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/22/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/22/2018

Labeler - Velocity Pharma LLC (962198409)

Registrant - Velocity Pharma LLC (962198409)

Establishment
Name	Address	ID/FEI	Business Operations
Yash Pharmaceuticals		871409551	manufacture(76168-401)