PAIN RELIEVING- camphor (natural) liniment

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

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Active ingredient:
CAMPHOR 3.5 %
Available from:
J.R. Watkins, LLC.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
EXTERNAL ANALGESIC for temporary relief of minor aches and pains of muscles and joints associated with - simple backache - arthritis - strains - bruises - sprains
Authorization status:
OTC monograph not final
Authorization number:
72342-040-25

PAIN RELIEVING- camphor (natural) liniment

J.R. Watkins, LLC.

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.

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Pain Relieving Liniment

Drug Facts

Active ingredients

CAMPHOR 3.5 %

Purpos e

EXTERNAL ANALGESIC

Us es

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

simple backache

arthritis

strains

bruises

sprains

Warnings

For external use only

Flammable: Keep away from fire or flame.

Do not use

on wounds or damaged skin

with a heating pad

When using this product

avoid contact with eyes, nostrils and mouth

do not bandage tightly

do not rub onto skin

Stop use and ask a doctor if

condition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

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

away.

Directions

Lift silver tab to open

Use only as directed

Adults and children 2 years and older: Pat onto affected area not more than 3–4 times daily.

Children under 2 years of age: Ask a doctor.

Other information

close container tightly and store at room temperature away from heat (dry, well-ventilated premises

at 59-77°F)

Inactive ingredients

annatto extract, capsicum oleoresin, carmine, glycerin, polysorbate 80, potassium carbonate, potassium

cocoate, propylene glycol, SD alcohol 40B, spruce oil, water.

Questions or Comments?

1-888-384-1945

PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

ESTD

1868

J.R.

WATKINS

REMEDIES FOR BODY™

PAIN RELIEVING

LINIMENT

EXTERNAL ANALGESIC

CAMPHOR

RELIEF FOR

SIMPLE BACKACHE

ARTHRITIS SPRAINS

MUSCLE STRAINS

SIMPLY RUB ONTO SKIN

FOR RELIEF

FLAMMABLE KEEP AWAY

FROM FIRE, SPARKS AND

HEATED SURFACES

11 FL OZ (325 mL)

PAIN RELIEVING

camphor (natural) liniment

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:72342-0 40

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CAMPHO R ( NATURAL) (UNII: N20 HL7Q9 41) (CAMPHOR (NATURAL) -

UNII:N20 HL7Q9 41)

CAMPHOR (NATURAL)

3.5 g in 10 0 mL

J.R. Watkins, LLC.

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

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

PICEA MARIANA LEAF O IL (UNII: Q1J49 L1A5O)

Po ta ssium Co co a te (UNII: F8 U72V8 ZXP)

CAPSICUM O LEO RESIN (UNII: UW8 6 K58 1WY)

Po ta ssium Ca rbo na te (UNII: BQN1B9 B9 HA)

ANNATTO (UNII: 6 PQP1V1B6 O)

Glycerin (UNII: PDC6 A3C0 OX)

Po lyso rba te 8 0 (UNII: 6 OZP39 ZG8 H)

Pro pylene Glyco l (UNII: 6 DC9 Q16 7V3)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:72342-0 40 -25

325 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 9 /0 1/20 19

Labeler -

J.R. Watkins, LLC. (081071049)

Revised: 8/2019

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