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NDC 70170-0017-01 eos THE FIXER HEAL REPAIR MEDICATED ANALGESIC LIP .0475; .0475; .0594 g/10mL; g/10mL; g/10mL Details

eos THE FIXER HEAL REPAIR MEDICATED ANALGESIC LIP .0475; .0475; .0594 g/10mL; g/10mL; g/10mL

eos THE FIXER HEAL REPAIR MEDICATED ANALGESIC LIP is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by eos Products LLC. The primary component is ALLANTOIN; CAMPHOR (NATURAL); MENTHOL.

Product Information

NDC	70170-0017
Product ID	70170-0017_923d6b66-42f4-4461-9885-b806f5e74ddd
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	eos THE FIXER HEAL REPAIR MEDICATED ANALGESIC LIP
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol, Camphor, Allantoin
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	.0475; .0475; .0594
Active Ingredient Units	g/10mL; g/10mL; g/10mL
Substance Name	ALLANTOIN; CAMPHOR (NATURAL); MENTHOL
Labeler Name	eos Products LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70170-0017-01 (70170001701)

Pricing Information	N/A
NDC Package Code	70170-0017-1
Billing NDC	70170001701
Package	1 TUBE in 1 BLISTER PACK (70170-0017-1) / 10 mL in 1 TUBE
Marketing Start Date	2020-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 08f2e9cf-89b5-4a22-bb1d-fc4673f7b2b0 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients Purpose

Menthol 0.625% External Analgesic

Camphor 0.50% External Analgesic

Allantoin 0.50% Lip Protectant

Uses

For the temporary relief of pain associated with fever blisters and cold sores.
Temporarily protect minor cuts, scrapes, burns, chapped or cracked lips.

Warnings

For external use only.

SPL UNCLASSIFIED SECTION

When using this product avoid contact with eyes.

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.

Directions

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

Inactive Ingredients:

Bis-Diglyceryl Polyacyladipate-2, Jojoba Esters, Hydrogenated Polyisobutene, Ricinus Communis (Castor) Seed Oil, Dimer Dilinoleyl Dimer Dilinoleate, Diiosteryl Malate, Octyldodecanol, Nylon-12, Beeswax/Cera Alba (Cire d'abeille), Helianthus Annuus (Sunflower) Seed Wax, Flavor (Armoa), Silica Dimethyl Silylate, Butyrospermum Parkii (Shea) Butter, Theoborma Cacao (Cocoa) Seed Butter, Mentha Piperita (Peppermint) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Acacia Decurrens Flower Wax, Stearalkonium Hectorite, Polyglycerin-3, Propylene Carbonate, Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Citric Acid, Limonene1. 1Component of Flavor.

Questions or comments?

(866) 547-4367

Principal Display Pantel - 0.35 fl. oz. (10 mL)

eos

THE FIXER

HEAL + REPAIR

MEDICATED

ANALGESIC LIP OINTMENT

COLD SORE, FEVER BLISTER TREATMENT

HELPS HEAL + REPAIR DRY LIPS

PROTECTIVE MOISTURE BARRIER

+NATURAL MINT EXTRACT

INSTANT COOLING RELIEF

NET 0.35 fl. oz. (10 mL)

INGREDIENTS AND APPEARANCE

EOS THE FIXER HEAL REPAIR MEDICATED ANALGESIC LIP

menthol, camphor, allantoin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70170-0017
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.0594 g in 10 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	0.0475 g in 10 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.0475 g in 10 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
YELLOW WAX (UNII: 2ZA36H0S2V)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
CASTOR OIL (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
COCOA BUTTER (UNII: 512OYT1CRR)
SHEA BUTTER (UNII: K49155WL9Y)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
DIMER DILINOLEYL DIMER DILINOLEATE (UNII: 0E2D5DBT7M)
NYLON-12 (UNII: 446U8J075B)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TOCOPHEROL (UNII: R0ZB2556P8)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70170-0017-1	1 in 1 BLISTER PACK	07/01/2020
1		10 mL in 1 TUBE; 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	07/01/2020

Labeler - eos Products LLC (803969620)

Name	Address	ID/FEI	Business Operations
Establishment
Raining Rose, Inc.		083819404	manufacture(70170-0017)

Revised: 5/2020

Document Id: 923d6b66-42f4-4461-9885-b806f5e74ddd

Set id: 08f2e9cf-89b5-4a22-bb1d-fc4673f7b2b0

Version: 1

Effective Time: 20200522

Search by Drug Name or NDC

NDC 70170-0017-01 eos THE FIXER HEAL REPAIR MEDICATED ANALGESIC LIP .0475; .0475; .0594 g/10mL; g/10mL; g/10mL Details

eos THE FIXER HEAL REPAIR MEDICATED ANALGESIC LIP .0475; .0475; .0594 g/10mL; g/10mL; g/10mL

Product Information

Package

Package Images

NDC 70170-0017-01 (70170001701)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 08f2e9cf-89b5-4a22-bb1d-fc4673f7b2b0 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Inactive Ingredients:

Questions or comments?

Principal Display Pantel - 0.35 fl. oz. (10 mL)

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