COLD ZONE PAIN RELIEVING GEL- DG HEALTH- menthol gel 
Velocity Pharma LLC

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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Cold Zone Pain Relieving Gel- DG Health

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:


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:


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

2018-01-17-PHOTO-00000024

COLD ZONE PAIN RELIEVING GEL- DG HEALTH 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-451
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-451-4159.14 mL in 1 BOTTLE; Type 0: Not a Combination Product01/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/22/2018
Labeler - Velocity Pharma LLC (962198409)

Revised: 5/2018
Document Id: 6c2fe3ca-a4b4-2cac-e053-2a91aa0aa4be
Set id: 441a88dc-4d6c-4c5a-97fe-80e392e35d95
Version: 2
Effective Time: 20180514
 
Velocity Pharma LLC