EOS MEDICATED COOLING CHAMOMILE- menthol stick EOS MEDICATED COOLING CHAMOMILE- menthol stick

eos Medicated Cooling Chamomile by

Drug Labeling and Warnings

eos Medicated Cooling Chamomile by is a Otc medication manufactured, distributed, or labeled by eos Products LLC, Raining Rose, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Warnings

For external use only

ACTIVE INGREDIENT

PURPOSE

Active ingredients Purpose

Menthol 0.5%                      External analgesic

Uses

For the temporary relief of pain and itching associated with fever blisters, cold sores, sunburn or minor skin irritations.

WHEN USING

When using this product avoid contact with the eyes.

STOP USE

Stop use and ask a doctor if

   -Condition worsens.

   -Symptoms persist 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 2 years of age and older: Apply to lips not more than 3 or 4 times daily.
• Children under 2 years of age: ask a doctor.

Inactive Ingredients:

Beeswax/Cera Alba (Cire d’abeille), Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Bis-Diglyceryl Polyacyladipate-
2, Jojoba Esters, Cocos Nucifera (Coconut) Oil, Flavor (Aroma), Oryza Sativa (Rice) Bran Wax, Helianthus Annuus (Sunflower) Seed Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Acacia Decurrens Flower Wax, Aloe Barbadensis Leaf
Juice, Chamomilla Recutita (Matricaria) Flower Extract, Stevia Rebaudiana Leaf/Stem Extract, Tocopherol, Polyglycerin-3, Glycine Soja (Soybean) Oil, Citric Acid

Other information

• Protect this product from excessive heat and direct sun.

Questions?

(866) 547-4367

Principal Display Pantel - .025 oz (7 g)

eos

Medicated Cooling Chamomile

Lip Balm

Net wt. 0.25 oz (7 g)

INGREDIENTS AND APPEARANCE

EOS MEDICATED COOLING CHAMOMILE 
menthol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70170-0011
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.035 g  in 7 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
JOJOBA OIL (UNII: 724GKU717M)
COCONUT OIL (UNII: Q9L0O73W7L)
RICE BRAN (UNII: R60QEP13IC)
SUNFLOWER SEED (UNII: R9N3379M4Z)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
ALOE (UNII: V5VD430YW9)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
SOYBEAN OIL (UNII: 241ATL177A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	white	Score
Shape	ROUND	Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70170-0011-1	1 in 1 BLISTER PACK	12/13/2017
1		7 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/13/2017

EOS MEDICATED COOLING CHAMOMILE 
menthol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70170-0012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.035 g  in 7 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
JOJOBA OIL (UNII: 724GKU717M)
COCONUT OIL (UNII: Q9L0O73W7L)
RICE BRAN OIL (UNII: LZO6K1506A)
SUNFLOWER SEED (UNII: R9N3379M4Z)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
ALOE (UNII: V5VD430YW9)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
SOYBEAN OIL (UNII: 241ATL177A)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	white	Score
Shape	ROUND	Size
Flavor	MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70170-0012-1	1 in 1 CELLO PACK	12/13/2017
1		7 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/13/2017

Labeler - eos Products LLC (803969620)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose, Inc.		083819404	manufacture(70170-0011, 70170-0012)