Search by Drug Name or NDC

NDC 59316-0003-18 2 in 1 Relief Value Pack Details

2 in 1 Relief Value Pack

2 in 1 Relief Value Pack is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is .

Product Information

NDC	59316-0003
Product ID	59316-003_b58456b8-d43d-4d47-8ffe-91c594ab331c
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	2 in 1 Relief Value Pack
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	RB Health (US) LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	n/a

Package

Package Images

NDC 59316-0003-18 (59316000318)

Pricing Information	N/A
NDC Package Code	59316-003-18
Billing NDC	59316000318
Package	1 KIT in 1 KIT (59316-003-18) * 1 PACKET in 1 POUCH (59316-993-07) / 1 PATCH in 1 PACKET / 9 g in 1 PATCH
Marketing Start Date	2020-09-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 06c53084-f8a3-4aac-9d6d-70568e2f73cd Details

Drug Facts

Active Ingredients

Menthol 5%

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

Ask a doctor before use if you have:

Sensitive skin

When using this product:

• Use only as directed • Avoid contact with 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 • Wash hands after use with cool water • Do not bandage or use with heating pad or device • Store in a cool dry place away from direct sunlight

Stop use and ask a doctor if:

You experience pain, swelling or blistering; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

If pregnant or breastfeeding:

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 12 years of age and older: Clean and dry affected area, pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use

• Children under 12 years of age: Consult physician

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Diazolidinyl Urea, Dihydroxyaluminum Aminoacetate, Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions or Comments:

1-800-246-3733

Package Labeling:

INGREDIENTS AND APPEARANCE

2 IN 1 RELIEF VALUE PACK

menthol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59316-003

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59316-003-18	1 in 1 KIT	09/30/2020	12/31/2024

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	2 PATCH	18 g

Part 1 of 1
BIOFREEZE menthol patch

Product Information
Item Code (Source)	NDC:59316-993
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.05 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
GLYCERIN (UNII: PDC6A3C0OX)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:59316-993-07	1 in 1 POUCH
1		1 in 1 PACKET
1		9 g in 1 PATCH; 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	09/30/2020	12/31/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/30/2020	12/31/2024

Labeler - RB Health (US) LLC (081049410)

Revised: 12/2021

Document Id: b58456b8-d43d-4d47-8ffe-91c594ab331c

Set id: 06c53084-f8a3-4aac-9d6d-70568e2f73cd

Version: 2

Effective Time: 20211217