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Package Insert and Label Information: Kool Comfort Pain Relieving Roll-On

By Wonder Laboratories | Last revised: 1 January 2009

KOOL COMFORT PAIN RELIEVING ROLL-ON — menthol lotion
Wonder Laboratories

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.

Active Ingredient: Purpose

Natural Menthol USP 3.5%…………………………………………….Cooling Pain Relief

Uses: Temporary relief of minor aches and pains of sore muscles and joints

associated with — arthritis — backache — strains — sprains

Warnings: For external use only

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have: Sensitive Skin

When Using This Product: Avoid contact with eyes or mucous membranes


Stop Use And Ask A Doctor If: Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding: Ask a health professional before use.

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center right away

- Adults and children 2 years of age and older: Roll on to the affected areas not more than 4 times daily; massage not necessary

- Children under 2 years of age: Consult a physician

Other Information: Store in a cool dry place with lid tightly closed

Inactive Ingredients: carbomer, FDC blue #1, FDC yellow #5, , glycerine, herbal extract (ILEX paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol USP, silicon dioxide, triethanolamine USP, water

Product Label
(click image for full-size original)
KOOL COMFORT PAIN RELIEVING ROLL-ON
menthol lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:99528-3590
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (Menthol) Menthol 3.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
Water
FD&C Blue No. 1
FD&C Yellow No. 5
CARBOMER HOMOPOLYMER TYPE C
Silicon Dioxide
Glycerin
Propylene Glycol
ILEX PARAGUARIENSIS LEAF
Methylparaben
Isopropyl Alcohol
Camphor (Synthetic)
Trolamine
Product Characteristics
Color green (mint green) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:99528-3590-3 100 g in 1 BOTTLE, WITH APPLICATOR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/01/2009
Labeler — Wonder Laboratories (078294223)
Registrant — U.S. Pharmaceuticals (009248480)
Establishment
Name Address ID/FEI Operations
U.S. Pharmaceuticals, Inc. 009248480 manufacture

Revised: 01/2009 Wonder Laboratories

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