FAMILY WELLNESS ICE BLUE- menthol gel 
FAMILY DOLLAR SERVICES INC

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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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

label

FAMILY WELLNESS ICE BLUE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-990
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-990-01226 g in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2020
Labeler - FAMILY DOLLAR SERVICES INC (024472631)
Registrant - FAMILY DOLLAR SERVICES INC (024472631)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(55319-990)

Revised: 6/2020
Document Id: abf4cdea-1a9c-7c8e-e053-2a95a90a83a5
Set id: abf4cdea-1a9b-7c8e-e053-2a95a90a83a5
Version: 1
Effective Time: 20200601
 
FAMILY DOLLAR SERVICES INC