FAMILY WELLNESS ICE BLUE- menthol gel

FAMILY WELLNESS ICE BLUE by

Drug Labeling and Warnings

FAMILY WELLNESS ICE BLUE by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR SERVICES INC, Ningbo Liyuan Daily Chemical Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 2 percentage

Purpose

External pain reliever

Uses

Temporary relief of minor pains of muscle and joints associated with

simple back ache

arthritis

sprains, strains or bruises

Warnings

Do not use internally, with heating pads or devices, on wounds or damaged skin.

For external use only.

Ask a doctor before use if you have sensitive skin.

When using this product

Use only as directed

do not bandage tightly

avoid contact with eyes and mucus membranes

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

skin irritation develops

If you are pregnant or nursing a baby,

concult a physician before use.

KEEP OUT OF REACH OF CHILDREN.

DO NOT APPLY TO CHILDREN UNDER 2 YEARS OF AGE.

In case of accidental ingestion, get medical help or contact a Posion Control Center immediately.

Directions

Adult and children 2 years of age and older:

Clean skin thoroughly. Apply liberally to affected area not more than 3-4 times daily. No protective cover needed.

May be used with ice packs.

May be used with wet or dry bandages, but wrap loosely.

Children under 2 years of age, consult a doctor.

Other information

store between 59 - 86 Fahrenheit (15 - 30 degrees Celsius) keep tightly closed

do not use, pour, spill or store near heat or open flame.

Inactive ingredients

Blue 1, Camphor, Carbomer, Isopropyl Alcohol, Methylchoroisothiazolinone, Methylisothiazolinone, Sodium Hydroxide, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS ICE BLUE 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-990
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
WATER (UNII: 059QF0KO0R)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER 934 (UNII: Z135WT9208)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-990-01	226 g in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2020

Labeler - FAMILY DOLLAR SERVICES INC (024472631)

Registrant - FAMILY DOLLAR SERVICES INC (024472631)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Liyuan Daily Chemical Products Co., Ltd.		530766098	manufacture(55319-990)