Quickflex (Menthol) Cream [Access Business Group International Llc] -

QUICKFLEX (MENTHOL) CREAM [ACCESS BUSINESS GROUP INTERNATIONAL LLC]
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NDC	10056-135-01
Set ID	08f7c158-29c2-4d56-9f70-b6e40a2d3efe
Category	HUMAN OTC DRUG LABEL
Packager	Access Business Group International LLC
Generic Name
Product Class
Product Number
Application Number	PART348

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Active Ingredient

Menthol 1.25%
Purpose

Pain relieving cream
Use

Temporarily relieves minor aches and pains of muscles
and joints associated with:
simple backache
arthritis
strains
bruises
sprains
Warnings

For external use only
Do not use

on wounds or damaged skin
When using this product
- avoid contact with eyes or mucous membranes
- do not bandage tightly
Stop use and ask a doctor if
- condition worsens or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
Keep out of reach of children
Directions
- Adult and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
- Children under 2 years of age: consult a physician.
Inactive Ingredients

aloe vera gel, cetyl alcohol, cetyl esters, cinnamon oil, eucalyptus oil, glyceryl stearate, grape seed oil, hypromellose, jojoba oil, peppermint oil, potassium sorbate, purified water, squalane, stearic acid, stearyl alcohol, tea tree oil, vegetable glycerin, wintergreen oil.
PRINCIPAL DISPLAY PANEL

Image of the principal display panel

INGREDIENTS AND APPEARANCE

QUICKFLEX
menthol cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
CINNAMON OIL (UNII: E5GY4I6YCZ)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYPROMELLOSE (UNII: 3NXW29V3WO)
PEPPERMINT OIL (UNII: AV092KU4JH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
GRAPE SEED OIL (UNII: 930MLC8XGG)
JOJOBA OIL (UNII: 724GKU717M)
TEA TREE OIL (UNII: VIF565UC2G)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CETYL ESTERS WAX (UNII: D072FFP9GU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10056-135-01	85 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/30/2010

Labeler - Access Business Group International LLC (609682641)

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Medic