KOFAL- methyl salicylate ointment

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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Download 제품 특성 요약 (SPC)
22-04-2024

유효 성분:

METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

제공처:

Pharmadel LLC

관리 경로:

TOPICAL

처방전 유형:

OTC DRUG

치료 징후:

Purpose External Analgesic For the temporary relief of minor aches and pains of muscles and joints associated with: - simple backache - arthritis - strains - sprains

승인 상태:

OTC monograph not final

제품 특성 요약

                                KOFAL- METHYL SALICYLATE OINTMENT
PHARMADEL LLC
----------
KOFAL FUERTE OINTMENT 2 OZ (KENIL)
_ACTIVE INGREDIENTS & PURPOSE_
PURPOSE
External Analgesic
_ACTIVE INGREDIENT_
_PURPOSE_
Methyl Salicylate 10.5%.............................
External Analgesic
_USES_
For the 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.
_DO NOT USE_
on broken or irritated skin
with a tight bandage
with a heating pad
STOP USE AND ASK DOCTOR IMMEDIATELY IF
condition worsens
symptoms persist for more than 7 days or clear up and occur again
within a few
days
excessive skin irritation occurs
IF PREGNANT OR BREAST-FEEDING,
ask a health care professional before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed get medical help, or contact a Poison Control Center
immediately.
_DIRECTIONS_
adults and children 12 years of age and older: apply to affected area
not more than 3
to 4 times daily
children under 12 years of age: consult a doctor
_OTHER INFORMATION_
store between 59° to 86°F (15° to 25°C)
do not use if clear seal over jar is broken, torn or missing
_INACTIVE INGREDIENTS_
camphor, menthol, methylparaben, paraffin, petrolatum, propylparaben.
_QUESTIONS OR COMMENTS?_
1-866-359-3478 M-F 9 AM - 5 PM EST or www.pharmadel.com
DISTRIBUTED BY/ DISTRIBUIDO POR:
Pharmadel LLC, Georgetown, DE 199747
PACKAGE LABEL & PRINCIPAL DISPLAY PANEL
KOFAL
methyl salicylate ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:55758-109
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID -
UNII:O414PZ 4LPZ )
METHYL SALICYLATE
10.5 g in 100 g
Pharmadel LLC
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CAMPHOR, (-)- (UNII: 213N3S8275)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PETROLATUM (UNII: 4
                                
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