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NDC 73287-0004-01 Hempvana Cold As Ice 8 mg/100mL Details

Hempvana Cold As Ice 8 mg/100mL

Hempvana Cold As Ice is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Telebrands Corp. The primary component is MENTHOL.

Product Information

NDC	73287-0004
Product ID	73287-004_c71ab94e-b7a8-6180-e053-2a95a90af6a0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Hempvana Cold As Ice
Proprietary Name Suffix	Pain Relief
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	8
Active Ingredient Units	mg/100mL
Substance Name	MENTHOL
Labeler Name	Telebrands Corp
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 73287-0004-01 (73287000401)

Pricing Information	N/A
NDC Package Code	73287-004-01
Billing NDC	73287000401
Package	1 BOTTLE, WITH APPLICATOR in 1 CARTON (73287-004-01) / 74 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date	2019-06-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 95e84bb9-ba2e-5009-e053-2995a90a4362 Details

Drug Facts

Active Ingredient:

Menthol USP 8% w/w

Purpose

Menthol USP 8% w/w................Topical Analgesic

Uses

temporarily relief of minor aches and pains of muscles and joints associated with:

• simple backache • arthritis • strains • bruises • sprains

Warnings

For external use only

Flammable: Keep away from excessive heat or open flame

When using this product, avoid contact with eyes.

Do nut use in large quantities, particularly over raw surfaces or blistered areas.
Do not apply to wounds or damaged skin
Do not bandage tightly

Stop use and ask a doctor if

Condition worsens
Symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults: Apply to affected are not more than 3 to 4 times daily. If produce comes in contact with hands, wash with soap and water.

For children under 18 years of age: Consulta a physician.

SPL UNCLASSIFIED SECTION

Store tightly closed in a cool dry place.

Inactive Ingredients

Arctium Lappa Root Extract, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor, Cannabis Sativa Seed Oil, Carbomer, FD&C Blue No 1, FD&C

Yellow No 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water

Questions?

Call (855) 877-4503 (M-F, 9am-5pm EST)

Packaging

INGREDIENTS AND APPEARANCE

HEMPVANA COLD AS ICE PAIN RELIEF

menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73287-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS (UNII: YF70189L0N)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73287-004-01	1 in 1 CARTON	06/11/2019
1		74 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/11/2019

Labeler - Telebrands Corp (177266558)

Name	Address	ID/FEI	Business Operations
Establishment
A.I.G. TECHNOLOGIES, INC.		086365223	manufacture(73287-004)

Revised: 7/2021

Document Id: c71ab94e-b7a8-6180-e053-2a95a90af6a0

Set id: 95e84bb9-ba2e-5009-e053-2995a90a4362

Version: 3

Effective Time: 20210714