PAIN RELIEVING- menthol, camphor gel

Pain Relieving by

Drug Labeling and Warnings

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

Drug Details [pdf]

DRUG FACTSActive Ingredient

Menthol 3.5%

Camphor 0.2%

Purpose

Topical Analgesic

Keep out of reach of children

Keep  out of reach of children.

If swallowed, get medical help or contact a poison control center immediately.

Indications

For temporary relief from minor aches and pains of sore muscles and joints associated with arthritis pain, backache, strains, and sprains.

Warnings

Use only as directed. For external use only. Do not use with other sprays, ointments, creams, or liniments. Do not apply to irritated skin and discontinue use if excessive skin irritation develops. Do not bandage. Do not use with heating pads or devices. When using this product avoid contact with the eyes or mucous membranes. Ask your physician before using on children under two years of age, or if you are pregnant, nursing, or have sensitive skin.

If condition worsen, or if symptoms persist for more than 7 days, or clear up and then recur within a few days, stop use and contact your physician.

Directions

Apply to the affected areas not more than 3-4 times daily.

Rinse hands with cool water.

Other Information

Store in a cool, dry place with lid closed tightly. Keep away from excessive heat or open flame.

Inactive Ingredients

Water, SDA Alcohol 40-B, Carbomer, isopropyl Alcohol, Glycerine, llex Paraguariensis Leaf Extract, Camellia Sinensis (Green Tea) Leaf Powder, Glycerine, Capsaicin, FD&C Blue #1, FD&C Yellow #5, Triethanolamine

Pain Relieving Gel product label

NDC: 63347-215-02

Pain Relieving Gel

PRACTICE
EXCLUSIVE

Menthol 3.5%

Camphor 0.2%

Capsaicin 0.01%

6.0 FL OZ

Manufactured by:
Blaine Labs Inc.

11037 Lockport Place

Santa Fe Springs, CA 90670

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INGREDIENTS AND APPEARANCE

PAIN RELIEVING 
menthol, camphor gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-215
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 mg  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	0.2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
CARBOMER 934 (UNII: Z135WT9208)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERIN (UNII: PDC6A3C0OX)
CAPSAICIN (UNII: S07O44R1ZM)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-215-01	88.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	04/01/2016
2	NDC: 63347-215-02	177 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2016
3	NDC: 63347-215-03	946.4 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/01/2016

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-215)