FOOTSCRIPTIONS FOOT REPAIR- menthol cream 
Donegal Bay Ltd

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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Daily Moisturizing Lotion

Active Ingredient:

Menthol USP 0.1%

Purpose:

External Analgesic

Uses:

Temporarily relieves pain and itching associated with skin irritations

Warnings:

For external use only

When using this product, avoid contacting with eyes

Stop use and ask a doctor if condition worsens or if symptoms last for more than 7 days or clear up and occur again within a few days

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Direction:

Adults and children 2 years and older: apply up to 3-4 times daily.

Under 2 years: ask a doctor

Wash and dry feet, apply liberally over feet, between toes, on bottoms of feet, and message until absorbed.

Inactive Ingredients:

Aloe Barbadenis Leaf Juice, Water, Mineral Oil, Glycerryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Cetearyl Alcohol, Polysorbate 60, Propylene Glycol, Stearic Acid, Hydrogenated Polyisobutene, Dimethicone, Triethanolamine, Salicylic Acid, Imidazlidinyl, Urea, Chondrus Crispus, Methylparaben, Propylparaben, Mentha Piperita (peppermint) Oil, Chloroxylenol, DMDM Hydantoin

image description

FOOTSCRIPTIONS FOOT REPAIR 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70990-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE ANDONGENSIS LEAF (UNII: N1P4NU25EJ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MINERAL OIL (UNII: T5L8T28FGP)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
UREA (UNII: 8W8T17847W)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70990-002-01252 mL in 1 TUBE; Type 0: Not a Combination Product10/12/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/12/2016
Labeler - Donegal Bay Ltd (068443618)
Registrant - Donegal Bay Ltd (068443618)
Establishment
NameAddressID/FEIBusiness Operations
HANGZHOU KARIC COMMODITIES CO., LTD526884335manufacture(70990-002)

Revised: 10/2016
Document Id: f64728fc-302c-4e7f-9df7-5448cd7fa67f
Set id: aa33d301-a56c-4519-a044-d56b53c7205c
Version: 1
Effective Time: 20161012
 
Donegal Bay Ltd