PAIN RELIEF- arnica, menthol crystals, cinnamon, peppermint, ginger, rosemary salve
SnugsZ USA

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Pain Relief Homeopathic Salve

OTC Purpose Pain Relief

Purpose

OTC Active Ingredients Pain Relief

Active Ingredients

Indications & Usage Pain Relief

Indications & Usage

Warnings Pain Relief

Warnings

Keep Out of Reach of Children Pain Relief

Warnings-Children

Storage and Handling Pain Relief

Storage-Handling

Dosage & Administration Pain Relief

Dosage

Inactive Ingredients Pain Relief

Inactive Ingredients

Pain Relief Principal Display Panel

principal display panel

PAIN RELIEF
arnica, menthol crystals, cinnamon, peppermint, ginger, rosemary salve

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76309-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	3.82 g in 17 g
SUNFLOWER OIL (UNII: 3W1JG795YI) (SUNFLOWER OIL - UNII:3W1JG795YI)	SUNFLOWER OIL	3.82 g in 17 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.04 g in 17 g
ROSEMARY OIL (UNII: 8LGU7VM393) (ROSEMARY OIL - UNII:8LGU7VM393)	ROSEMARY OIL	0.01 g in 17 g
CINNAMON OIL (UNII: E5GY4I6YCZ) (CINNAMON OIL - UNII:E5GY4I6YCZ)	CINNAMON OIL	0.01 g in 17 g
GINGER OIL (UNII: SAS9Z1SVUK) (GINGER OIL - UNII:SAS9Z1SVUK)	GINGER OIL	0.01 g in 17 g
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9)	MENTHA PIPERITA	0.03 g in 17 g

Ingredient Name	Strength
Inactive Ingredients
OLIVE OIL (UNII: 6UYK2W1W1E)	9.08 g in 17 g
YELLOW WAX (UNII: 2ZA36H0S2V)	4 g in 17 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76309-102-11	1 in 1 BOX	04/01/2016	02/07/2017
1	NDC:76309-102-04	17 g in 1 TUBE; Type 6: Drug/Biologic Combination
2	NDC:76309-102-09	1 in 1 BOX	04/01/2016	02/07/2017
2	NDC:76309-102-01	19.8 g in 1 CAN; Type 6: Drug/Biologic Combination
3	NDC:76309-102-10	1 in 1 BOX	04/01/2016	02/07/2017
3	NDC:76309-102-02	19.8 g in 1 CAN; Type 6: Drug/Biologic Combination
4	NDC:76309-102-12	1 in 1 BOX	04/01/2016	02/07/2017
4	NDC:76309-102-07	4.25 g in 1 TUBE; Type 6: Drug/Biologic Combination

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/01/2016	02/07/2017

Labeler - SnugsZ USA (615959228)

Registrant - Sierra Sage Herbs LLC (006970452)

Name	Address	ID/FEI	Business Operations
Establishment
SnugsZ USA		615959228	manufacture(76309-102) , label(76309-102) , pack(76309-102)

Revised: 2/2017

Document Id: 480dc24e-87c2-55db-e054-00144ff88e88

Set id: 40800562-68ef-45be-e054-00144ff88e88

Version: 14

Effective Time: 20170208

SnugsZ USA