ENDONESIC- menthol, camphor gel

ENDONESIC by

Drug Labeling and Warnings

ENDONESIC by is a Otc medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

Menthol 3.5%

Camphor 0.2%

PURPOSE

PURPOSE

Menthol ........ Topical Analgesic

Camphor ....... Topical Analgesic

INDICATIONS & USAGE

USES: For temporary relief from minor aches

and pains of sore muscles and joints

associated with: arthritis pain backache

strains sprains

WARNINGS

WARNINGS: For external use only.

OTHER SAFETY INFORMATION

Flammable: Keep away from excessive heat or open flame.

ASK DOCTOR

Ask a doctor before use if you have:

Sensitive skinChildren

WHEN USING

When using this product: Avoid contact

with the eyes and/or mucous membranes Do

not use with other sprays, ointments, creams or

liniments Do not apply to irritated skin

Discontinue use if excessive skin irritation

develops Do not bandage Do not use with

heating pads or devices

STOP USE

Stop use and contact your physician if:

conditions worsen, if symptoms persist for

more than seven (7) days, or clear up and

reoccur.

PREGNANCY OR BREAST FEEDING

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

Children under 2 years of age: Consult physician

KEEP OUT OF REACH OF CHILDREN

Keep Out Of Reach Of Children: If swallowed,

get medical help or contact a poison control center

immediately.

DOSAGE & ADMINISTRATION

DIRECTIONS: Use only as directed. Rub a

thin film over the affected areas not more than

four (4) times daily. Rinse hands after use

with cool water.

OTHER SAFETY INFORMATION

OTHER INFORMATION: Store in a cool,

dry place with lid closed tightly.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Ethyl Alcohol, Deionized Water, Glycerin,

Propylene Glycol, Cannabis Sativa Seed Oil (Hemp Seed Oil),

Cannabidiol (CBD), Arnica Montana Flower Extract (Arnica Oil),

Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint)

Leaf Oil, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf

Extract, Hamamelis Virginiana (Witch Hazel) Extract, Melaleuca

Alternifolia (Tea Tree) Leaf Oil, Capsicum Annuum Fruit Extract,

Phenoxyethanol, Caprylyl Alcohol, Ethylhexyl Glycerin, Hexylene Glycol

Principal Display Panel

ENDONESIC ®

MAXIMUM
PAIN
RELIEF

NDC# 63347-710-10

ENDONESIC®

1.7 FL OZ (50.275mL)

menthol and camphor
in a gel containing capsaicin and hemp oil

PHYSICIAN FORMULATED PAIN-RELIEF GEL

MAXIMUM
PAIN
RELIEF

Goes on cool and
  progressively heats

Infused with Capsaicin,
  Hemp Oil, and Tea Tree Oil

Paraben-free formulation

Light formula absorbs into
  the skin rapidly

Longer lasting formula. One
  application offers relief for
  up to 4-6 hours

Provides fast relief from sore
  muscles, aches and pain

MADE IN USA

HEMP DERIVED

THC√Free

6   16728   0005   2

MANUFACTURED BY:
BLAINE LABS, INC
11037 LOCKPORT PLACE,
SANTA FE SPRINGS, CA 90670
www.BLAINELABS.com

PLVV-END-BX03          REV201 81 203

↓1.7 OZ Label↓

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INGREDIENTS AND APPEARANCE

ENDONESIC 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-710
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.7596 g  in 50.275 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.1006 g  in 50.275 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CANNABIDIOL (UNII: 19GBJ60SN5)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PEPPERMINT OIL (UNII: AV092KU4JH)
SPEARMINT OIL (UNII: C3M81465G5)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WITCH HAZEL (UNII: 101I4J0U34)
TEA TREE OIL (UNII: VIF565UC2G)
PAPRIKA (UNII: X72Z47861V)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLIC ALCOHOL (UNII: NV1779205D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-710-10	1 in 1 BOX	12/01/2018
1		50.275 mL in 1 TUBE; 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	12/01/2018

Labeler - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-710)