CALMADOL- camphor, menthol, methyl salicylate liniment

CALMADOL by

Drug Labeling and Warnings

CALMADOL by is a Otc medication manufactured, distributed, or labeled by Grandall Distributing Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients:

Camphor 6.00%

Menthol 1.90%

Methyl Salicylate 10.00%

Purpose:

External Analgesic

Uses

For prompt temporary relief of minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only

When using this product

• Avoid contact with eyes and mucous membranes
• Do not bandage tightly

Stop use and ask a doctor if

• Condition worsens or symptoms persist for more than 7 days
• symptoms clear up and occur again within few days.

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

Keep out of reach of childern. If swallowed, get medical help or contact a Poison Control Center immediately.

Do not use

• on wounds
• on damaged skin
• with heating pad
• on children under 12 years of age

Directions

• Use only as directed.
• Adults and chrldren older than 12 years of age, apply cream to the affected area not more than 3 to 4 trmes daily.
• For children less than 12 years of age: ask a doctor

Inactive Ingredients

Puified Water (Aqua), Stearic Acid, Glyceryl Stearate, Turpentine, Mentha Piperita (Pepperment) Oil, TEA-Lauryl Sulfate, Triethanolamine, Methylparaben, Propylparaben.

Package Labeling

ARTHRITIS

CALMADOL

NET WT. 6 oz (170.1G)

INGREDIENTS AND APPEARANCE

CALMADOL 
camphor, menthol, methyl salicylate liniment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48201-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	6 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.9 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
TURPENTINE (UNII: XJ6RUH0O4G)
PEPPERMINT OIL (UNII: AV092KU4JH)
LAURYL SULFATE (UNII: DIQ16UC154)
TROLAMINE (UNII: 9O3K93S3TK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48201-004-17	1 in 1 BOX	07/08/2015
1		170.1 g in 1 JAR; 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	07/08/2015

Labeler - Grandall Distributing Co., Inc. (044428324)

Establishment
Name	Address	ID/FEI	Business Operations
VEGE-KURL, INC.		021072509	manufacture(48201-004)