Udder Essence Better Balm Medicated (Menthol And Methyl Salicylate) Cream [Lc&g Distributing Inc.] -

UDDER ESSENCE BETTER BALM MEDICATED (MENTHOL AND METHYL SALICYLATE) CREAM [LC&G DISTRIBUTING INC.]
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PURPOSE

Medicated Better Balm is a topical aid for irritation from minor cuts, scrapes, scratches, and chapping.
WARNINGS

KEEP OUT OF REACH OF CHILDREN

Avoid contact with eyes.

For External use only.

Discontinue use if irritation occurs.

Not to be applied to deep or puncture wounds.
Directions

Apply liberally to clean exposed areas. Repeat as necessary.
Ingredients

Water, Mineral Oil, Glycerin, Cetearyl Alcohol, Stearic Acid, Propylene Glycol, Sorbitol, Glycol Stearate, Potassium Hydroxide, Lanolin, Methyl Paraben, Propyl Paraben, Menthol, Methyl Salicylate, Tocopherol Acetate (Vitamin E), Aloe Vera Gel, Retinyl Palmitate (Vitamin A), Cholecalciferol (Vitamin D), FD&C Blue #1.
Questions or Comments?

PO Box 6874, Spring Hill, FL 34611
PRINCIPAL DISPLAY PANEL - 454 Gram Jar

Vitamins
A, D and E
Aloe Vera Gel
Lanolin

Udder Essence

BETTER BALM
Medicated

Net Weight
16oz. (1LB.)
(454 grams)

INGREDIENTS AND APPEARANCE

UDDER ESSENCE BETTER BALM MEDICATED
menthol and methyl salicylate cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	0.25 g in 100 g
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Methyl Salicylate	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Mineral Oil (UNII: T5L8T28FGP)
Glycerin (UNII: PDC6A3C0OX)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Stearic Acid (UNII: 4ELV7Z65AP)
Propylene Glycol (UNII: 6DC9Q167V3)
Sorbitol (UNII: 506T60A25R)
Glycol Stearate (UNII: 0324G66D0E)
Potassium Hydroxide (UNII: WZH3C48M4T)
Lanolin (UNII: 7EV65EAW6H)
Methylparaben Sodium (UNII: CR6K9C2NHK)
Propylparaben Sodium (UNII: 625NNB0G9N)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Vitamin A (UNII: 81G40H8B0T)
Cholecalciferol (UNII: 1C6V77QF41)
FD&C Blue No. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:24465-879-16	454 g in 1 JAR
2	NDC:24465-879-03	85 g in 1 TUBE
3	NDC:24465-879-04	1816 g in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved Drug Other		03/01/2011

Labeler - LC&G Distributing Inc. (795315436)

Name	Address	ID/FEI	Business Operations
Establishment
Dynamic Pharmaceuticals Inc.		617660712	MANUFACTURE, API MANUFACTURE

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