INFLAMMATION OTC DEEP PAIN CARE COLD- camphor, menthol lotion

Inflammation OTC by

Drug Labeling and Warnings

Inflammation OTC by is a Otc medication manufactured, distributed, or labeled by Skin Deep. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Camphor (3.0%)

Menthol (2.6%)

Purpose

Topical Analgesic

Counterirritant

Uses

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

• simple backache
• arthritis
• strains
• sprains
  

Warnings

For external use only

Avoid contact with the eyes

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician

Do not apply to wounds or damaged skin

Do not bandage tightly

Keep out of reach of children

In case of accidental ingestion seek professional assistance or contact a poison control immediately

Directions

Adults and children 2 years of age and older- Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age- Consult a physician.

Inactive Ingredients

water, dimethyl sulfone, glycerin, glycine soja (soybean) oil, eucalyptus globulus oil, piper nigrum (pepper) seed extract, centipedia cunninghamii extract, arctium majus root (burdock) extract, mentha piperita (peppermint) leaf extract, artemisia absinthium, uncaria tomentosa extract, zingiber officinale (ginger) root oil, arnica montana flower extract, zingiber officinale (ginger) root extract, d-ribose, sodium polycrylate, c18-21 alkane, trideceth-6, tocopherol, phenoxyethanol, iodopropynyl butylcarbamate

Questions or Comments

Store between 35 F and 80 F

call 1-912-236-9430 weekdays

Principal Display Panel

Inflammation OTC

Deep Pain Care Cold

New wt 1.1 oz. (31 mL)

Manufactured by SkinDeep for SkinFit Distributors

Savannah, GA 31405

Tel: 912-236-9430

www.mwlabs.com

INGREDIENTS AND APPEARANCE

INFLAMMATION OTC  DEEP PAIN CARE COLD
camphor, menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45156-5610
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941)	Camphor (Natural)	18 g  in 600 g
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	16 g  in 600 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)
Black Pepper Oil (UNII: U17J84S19Z)
Soybean Oil (UNII: 241ATL177A)
Arctium Lappa Root (UNII: 597E9BI3Z3)
Peppermint (UNII: V95R5KMY2B)
Wormwood (UNII: F84709P2XV)
Cat's Claw (UNII: 9060PRM18Q)
Ginger Oil (UNII: SAS9Z1SVUK)
Arnica Montana (UNII: O80TY208ZW)
Ginger (UNII: C5529G5JPQ)
Trideceth-6 (UNII: 3T5PCR2H0C)
Alpha-Tocopherol (UNII: H4N855PNZ1)
Phenoxyethanol (UNII: HIE492ZZ3T)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45156-5610-2	1 in 1 BOX
1	NDC: 45156-5610-1	31 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	08/16/2011

Labeler - Skin Deep (833276566)

Establishment
Name	Address	ID/FEI	Business Operations
Skin Deep		833276566	manufacture