FOOTSCRIPTIONS FOOT REPAIR- menthol cream

Footscriptions Foot Repair by

Drug Labeling and Warnings

Footscriptions Foot Repair by is a Otc medication manufactured, distributed, or labeled by Donegal Bay Ltd, HANGZHOU KARIC COMMODITIES CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Menthol USP 0.1%

PURPOSE

Purpose:

External Analgesic

INDICATIONS & USAGE

Uses:

Temporarily relieves pain and itching associated with skin irritations

WARNINGS

Warnings:

For external use only

When using this product, avoid contacting with eyes

STOP USE

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

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FOOTSCRIPTIONS FOOT REPAIR 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70990-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70990-002-01	252 mL in 1 TUBE; Type 0: Not a Combination Product	10/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/12/2016

Labeler - Donegal Bay Ltd (068443618)

Registrant - Donegal Bay Ltd (068443618)

Establishment
Name	Address	ID/FEI	Business Operations
HANGZHOU KARIC COMMODITIES CO., LTD		526884335	manufacture(70990-002)