JOINT FORMULA 88 MAX PLUS - camphor cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)
Available from:
Sarati International, Inc.
INN (International Name):
CAMPHOR - UNII:5TJD82A1ET)
Composition:
CAMPHOR (SYNTHETIC) 3.18 g in 100 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical analgesic Temporarily relieves the minor aches and pains of joints and muscles associated with simple backache, arthritis, strains, bruises, sprains. - other than as directed - on wounds or damaged skin - with a heating pad - if you are allergic to any ingredient in this product - on a child under 12 with arthritis-like conditions - condition worsens, or if symptoms persists for more than 7 days or clears up and occurs again within a few days - skin redness or excessive irritation of the skin develops
Authorization status:
OTC monograph not final
Authorization number:
67676-002-01, 67676-002-02, 67676-002-03

JOINT FORMULA 88 MAX PLUS - camphor cream

Sarati International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts Active Ingredients

SHAKE BEFORE USE

Camphor 3.18%

Purpos e

Topical analgesic

Keep out of reach of children

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately

Us es

Temporarily relieves the minor aches and pains of joints and muscles associated with simple backache,

arthritis, strains, bruises, sprains.

Warnings

For External Use Only

Do not use

other than as directed

on wounds or damaged skin

with a heating pad

if you are allergic to any ingredient in this product

on a child under 12 with arthritis-like conditions

When using this product:

avoid contact with eyes, wounds, mucus membranes, irritated skin

do not bandage tightly

stop use and ask a doctor if:

condition worsens, or if symptoms persists for more than 7 days or clears up and occurs again

within a few days

skin redness or excessive irritation of the skin develops

Pregnant or breast-feeding

If pregnant or breast-feeding, ask a doctor before use.

Directions

adults and children 12 years of age and older: apply to affected area not more than3 to 4 times daily.

children under 12 years of age: ask a doctor

Other information

Store in a cool dry place 68 - 77 F (20 - 25 C)

Minor separation may occur, shake well before using.

Inactive ingredients

Acrylamide/Sodium Acryloydimethyl Taurate Copolymer, Aloe Barbadensis Leaf Juice, Amica Oil,

Behentrimonium Methosulfate, Caprylic/Capric Trigyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetyl

Alcohol, Cholecalciferol, Chondroitin Sulfate, Coenzyme Q 10, Corn Oil, Deionized Water, Emu Oil,

Glucosamine Sulfate, Glycerin, Green (Camellia Sinensis) Tea Extract, Isohexadecane, Peppermint

Oil*, Phenoxyethanol, Polysorbate 80, SD Alcohol, Shark Cartilage, Shea Butter, Sorbic Acid,

Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Yucca (Glauca) Root Extract.

* A source of natural metnol

Questions? Comments?

Call 1-800-684-9312 Weekdays between 9am to 5pm CST

Distributed by Pain Management Laboratories, Los Fresnos, TX Made in the USA

Product Label

Dr. Paul Nemiroff's Joint Formula 88 MAX PLUS Pain Relief Cream

NEW MAX PLUS PROFESSIONAL STRENGTH Now with VITAMINS C, D, E - More

ANTIOXIDANTS and BOTANICALS

Joint Formula 88 MAX PLUS - "It's the science that makes the difference!"

Dr. Paul Nemiroff's Joint Formula 88 MAX PLUS provides deep penetrating pain relief and is effective

in providing temporary relief from minor arthritis, simple backache, muscle aches, strains, bruises, and

sprains. Specifically, the ingredients in Joint Formula 88 MAX PLUS are clinically shown to work.

Joint Formula 88 MAX PLUS combines the science and power of camphor, natural menthol,

glucosamine, chondroitin, aloe, emu oil, shark cartilage, arnica, yucca extract, more vitamins C, D, E to

create a fast acting and easy-to-apply cream with no greasy residue. AND...IT REALLY WORKS!

Dr. Paul M. Nemiroff, PhD., M.D. F.A.C.S.

Nationally recognized Surgeon

Award winning Television Medical Correspondent

Recipient of "Humanitarian of the Year Award" for donating his time to operate of refugees

Author of over 100 articles, book chapters, and published research papers.

Dr. Nemiroff is an accomplished head and neck cancer and reconstructive surgeon and received his

M.D. from UCLA Medical School with surgical residencies at UCLA-Cedars-Sinai and the University

of Florida. Prior to becoming a surgeon he obtained a Ph.D. from Purdue University. He has received

over a dozen national awards including Best Surgical Research of the Year from the Society of Head

and Neck Surgeons, and awards from the American Cancer Society. He has done hundreds of "on air"

medical pieces as a medical correspondent for CBS and ABC television affiliates. Throughout his

career, he has performed more than 10,000 surgeries.

Net Wt 4.5 oz. (126 grams) Plus 1.5oz. (42 grams) Travel Size

JOINT FORMULA 88 MAX PLUS

camphor cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 76 76 -0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -

UNII:5TJD8 2A1ET)

CAMPHOR

(SYNTHETIC)

3.18 g

in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

SO DIUM ACRYLO YLDIMETHYLTAURATE (UNII: 2T9 Q6 EKI0 G)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

ARNICA MO NTANA (UNII: O8 0 TY20 8 ZW)

BEHENTRIMO NIUM METHO SULFATE (UNII: 5SHP745C6 1)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

CHO LECALCIFERO L (UNII: 1C6 V77QF41)

CHO NDRO ITIN SULFATE ( BO VINE) (UNII: 6 IC1M3OG5Z)

UBIDECARENO NE (UNII: EJ27X76 M46 )

CO RN O IL (UNII: 8 470 G57WFM)

WATER (UNII: 0 59 QF0 KO0 R)

EMU O IL (UNII: 3448 21WD6 1)

GLUCO SAMINE SULFATE (UNII: 1FW7WLR731)

GLYCERIN (UNII: PDC6 A3C0 OX)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

ISO HEXADECANE (UNII: 9 18 X1OUF1E)

PEPPERMINT O IL (UNII: AV0 9 2KU4JH)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

SHARK, UNSPECIFIED (UNII: KEK41AP35U)

SHEA BUTTER (UNII: K49 155WL9 Y)

SO RBIC ACID (UNII: X0 45WJ9 8 9 B)

TETRAHEXYLDECYL ASCO RBATE (UNII: 9 LBV3F0 7AZ)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

YUCCA GLAUCA RO O T (UNII: 1A15YBH7N1)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 76 76 -0 0 2-0 3

1 in 1 BOX

0 8 /0 1/20 13

1

NDC:6 76 76 -0 0 2-0 1

126 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:6 76 76 -0 0 2-0 2

42 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 1/20 13

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Sarati International, Inc.

OTC mo no graph no t final

pa rt348

0 8 /0 1/20 13

Labeler -

Sarati International, Inc. (160219770)

Registrant -

Sarati International, Inc. (160219770)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Sarati Internatio nal, Inc.

16 0 219 770

ma nufa c ture (6 76 76 -0 0 2)

Revised: 12/2018

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