INFLAMMATION OTC DEEP PAIN CARE COLD- camphor, menthol lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Camphor (Natural) (UNII: N20HL7Q941) (Camphor (Natural) - UNII:N20HL7Q941), Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)

Available from:

Skin Deep

INN (International Name):

Camphor - UNII:N20HL7Q941)

Composition:

Camphor (Natural) 18 g in 600 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic Counterirritant For temporary relief of minor aches and pains of muscles and joints associated with - simple backache - arthritis - strains - sprains

Authorization status:

OTC monograph final

Summary of Product characteristics

INFLAMMATION OTC DEEP PAIN CARE COLD- CAMPHOR, MENTHOL LOTION
SKIN DEEP
_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 INGREDIENT
Camphor (3.0%)
Menthol (2.6%)
PURPOS E
Topical Analgesic
Counterirritant
US ES
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: [phone]
www.mwlabs.com
INFLAMMATION OTC DEEP PAIN CARE COLD
camphor, menthol lotion
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:4