OUTBACK PAIN RELIEF- camphor 6%, menthol 16% cream

Outback Pain Relief by

Drug Labeling and Warnings

Outback Pain Relief by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Camphor 6%, Menthol 16%

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

For the temporary relief of minor aches and pain associated with simple backaches, arthritis, strains, bruises, and sprains.

WARNINGS

For external use only. When using this product use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes or mucous membranes, and do not apply to wounds or damaged skin. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding ask a health professional.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older apply generously to the affected area not more than 4 times daily. Children under 12 years of age: ask a doctor.

INACTIVE INGREDIENT

Benzyl Alcohol, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polyacrylamide, Sorbitan Olivate, Tocopherol, Vanilla Planifolia Fruit Extract, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OUTBACK PAIN RELIEF 
camphor 6%, menthol 16% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-987
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	6 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
TEA TREE OIL (UNII: VIF565UC2G)
TOCOPHEROL (UNII: R0ZB2556P8)
VANILLA BEAN (UNII: Q74T35078H)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
BENZYL ALCOHOL (UNII: LKG8494WBH)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-987-02	57 g in 1 TUBE; Type 0: Not a Combination Product	05/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/13/2021

Labeler - Derma Care Research Labs, LLC (116817470)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(72839-987)