ICE COLD ANALGESIC- menthol and camphor gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)

Available from:

Singhfam Corporation

INN (International Name):

MENTHOL

Composition:

MENTHOL 2 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Topical Analgesic Uses for the temporary relief of minor aches and pains in muscles and joints associated with: - simple backache - strains - sprains - sports injuries - arthritis - bruises Do not use - with other topical pain relievers - with heating pads or heating devices Stop use and ask doctor if - condition worsens - symptoms last more than 7 days or clean up and occur again within a few days - redness or irritation develops

Authorization status:

OTC monograph final

Summary of Product characteristics

ICE COLD ANALGESIC- MENTHOL AND CAMPHOR GEL
SINGHFAM CORPORATION
_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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ICE COLD ANALGESIC GEL
ACTIVE INGREDIENTS
Menthol 2.0%
Camphor 0.5%
PURPOS E
Topical Analgesic
US ES
for the temporary relief of minor aches and pains in muscles and
joints associated with:
simple backache
strains
sprains
sports injuries
arthritis
bruises
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
with other topical pain relievers
with heating pads or heating devices
WHEN USING THIS PRODUCT
do not use in or near eyes
do not apply to wounds or damaged skin
do not bandage tightly
STOP USE AND ASK DOCTOR IF
condition worsens
symptoms last more than 7 days or clean up and occur again within a
few days
redness or irritation develops
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use
KEEP OUT OF THE REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away
DIRECTIONS
clean affected area before applying product
adults and children 2 years of age and older: apply to affected area
not more than 3 to 4 times daily
INACTIVE INGREDIENTS
benzyl alcohol, butylated hydroxytoluene, carbopol, colour brillient
blue, creasmer RH 40, disodium
EDTA, isopropyl alcohol, propylene glycol, purified water and sodium
hydroxide
PRINCIPAL DISPLAY PANEL
ICE COLD ANALGESIC GEL
Topical Analgesic
NET WT.8 OZ (227g)
ICE COLD ANALGESIC
menthol and camphor gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:529 20 -134
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)
MENTHOL
2 g in 10 0 g
CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) (CAMPHOR (SYNTHETIC) -
UNII:5TJD8 2A1ET)
CAMPHOR
(SYNTHETIC)
0 .5 g
in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
BENZYL ALCO HO L (UNII: