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NDC 71317-0815-04 Goldies Pain Off 50 mg/mL Details

Goldies Pain Off 50 mg/mL

Goldies Pain Off is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Goldie's Biohealth, LLC. The primary component is CAMPHOR (SYNTHETIC).

Product Information

NDC	71317-0815
Product ID	71317-815_655897f0-707c-3f8e-e053-2a91aa0a7dd9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Goldies Pain Off
Proprietary Name Suffix	n/a
Non-Proprietary Name	CAMPHOR
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	50
Active Ingredient Units	mg/mL
Substance Name	CAMPHOR (SYNTHETIC)
Labeler Name	Goldie's Biohealth, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 71317-0815-04 (71317081504)

Pricing Information	N/A
NDC Package Code	71317-815-04
Billing NDC	71317081504
Package	120 mL in 1 JAR (71317-815-04)
Marketing Start Date	2017-03-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4a9d2992-071c-0f20-e054-00144ff88e88 Details

Drug Facts

Active ingredient:

Camphor 5.00%

Topical Analgesic

INDICATIONS:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and stains.

WARNINGS:

For external use only.

Do not apply

to wounds or damaged skin.
Avoid contact with eyes. If symptoms persist for more than seven days, discontinue use and consult physician.
Do not bandage tighty.

Keep out of reach of children.

If swallowed, consult physician.

If pregant or breast feeding,

contact physician before use.

DIRECTIONS:

Adults and children two-years of age or older: Apply to affected area not more than three to four daily.
Children under two-years of age: consult a physician.

Additional information:

Store at room temperature.

Other Ingredients:

Aloe Barbadensis (Aloe Vera Gel) Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Aqua (Deionized Water), Arnica Montana flower Extract, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cetyl Esters, Cetyl Myristoleate, Citrus Aurantium Dulcis (Orange) Oil, Dimethicone, DMDM Hydantion, Emu Oil, Ethoxydiglycol, Ethylexylglycerin, Ethylhexyl Palmitate, Eucalyptus Globulus Oil, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Pyridoxine HC1 (Vitamin B6), Steareth-21, Tocopherol

Package Labeling:

INGREDIENTS AND APPEARANCE

GOLDIES PAIN OFF

camphor cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71317-815
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
SHEA BUTTER (UNII: K49155WL9Y)
CETYL ESTERS WAX (UNII: D072FFP9GU)
CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
ORANGE OIL (UNII: AKN3KSD11B)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EMU OIL (UNII: 344821WD61)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
PEPPERMINT OIL (UNII: AV092KU4JH)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PYRIDOXINE (UNII: KV2JZ1BI6Z)
STEARETH-21 (UNII: 53J3F32P58)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71317-815-02	60 mL in 1 JAR; Type 0: Not a Combination Product	03/11/2017
2	NDC:71317-815-04	120 mL in 1 JAR; Type 0: Not a Combination Product	03/11/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/11/2017

Labeler - Goldie's Biohealth, LLC (080511185)

Revised: 2/2018

Document Id: 655897f0-707c-3f8e-e053-2a91aa0a7dd9

Set id: 4a9d2992-071c-0f20-e054-00144ff88e88

Version: 3

Effective Time: 20180216