Painkoolers Topical Analgesic (Menthol, Unspecified Form, Capsaicin) Gel [Ga Health And Beauty (Foshan) Co., Ltd] -

PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]
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NDC	70118-002-05
Set ID	d9e8b5c9-3c40-4917-ad56-5a38153ffa7e
Category	HUMAN OTC DRUG LABEL
Packager	GA Health and Beauty (FOSHAN) Co., Ltd
Generic Name
Product Class
Product Number
Application Number	PART348

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DRUG FACTS:
ACTIVE INGREDIENTS:

Menthol 5.00%

Capsaicin 0.05%

External Analgesic
USES:

For the temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, sprains, bruises and strains.
WARNINGS:

For external use only.

Use only as directed. Avoid contact with eyes and muccous membranes.

• Do not cover with bandage

Do not use

on wounds or damaged skin • Do not use in combination with any other external analgesic products • Avoid contact with eyes and maccous membranes • Do not use in combination with any external heat source. • Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment

Keep out of reach of children

• Consult physician for children under 12

• Do not use

if you are allergic or amenthol

• Stop use

and ask a doctor id conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days • Or Rash, itching or excessive skin irritation occurs.
DIRECTIONS:
- Adults and children 12 years and over apply to affected area.
- Change patch 1 to 2 times daily.
- Children under 12 years, consult physician before use.
How to apply:
- Clean and dry affected area
- Cut open pouch and remove patch
- Remove protected film and apply directly to area of pain
- Apply to affected area not more than 3 times daily
- Wash hands with soap after applying patch
- Reseal pouch containing unused patches
INACTIVE INGREDIENTS:

Purified Water,Glycerin,Polyvinyl Alcohol,Sodium Polyacrylate,Propylene Glycol,Polysorbate 80,Sorbitan Stearate,Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aanica Montana Extract, Rosemary Oil,Tartaric Acid,Dihydroxyaluminum Aminoacetate,Titanium Dioxide,Kaolin,Glydant Plus Liquid.
Package Labeling:

INGREDIENTS AND APPEARANCE

PAINKOOLERS TOPICAL ANALGESIC
menthol, unspecified form, capsaicin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70118-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5 g in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.05 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYVINYL ALCOHOL (UNII: 532B59J990)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (UNII: O80TY208ZW)
ROSEMARY OIL (UNII: 8LGU7VM393)
TARTARIC ACID (UNII: W4888I119H)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
KAOLIN (UNII: 24H4NWX5CO)

#	Item Code	Package Description
Packaging
1	NDC:70118-002-05	5 in 1 POUCH
1		8 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/21/2015

Labeler - GA Health and Beauty (FOSHAN) Co., Ltd (544333811)

Name	Address	ID/FEI	Business Operations
Establishment
GA Health and Beauty (FOSHAN) Co., Ltd		544333811	repack(70118-002) , relabel(70118-002)

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Medic

PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]

Do not use

Keep out of reach of children

• Do not use

• Stop use

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