Label: ABEJAS Y VIBORAS BRAND ROLL-ON- menthol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 53145-703-03 - Packager: MENPER DISTRIBUTORS INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated March 1, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
Do not use
- on wounds or damaged skin
- with a heating pad
- on a child 12 years of age and under
- over extensive areas of the body
- on irritated skin
- with a bandage
- with other ointments, creams, sprays or liniments
Ask a doctor before use if you have redness over the affected area.
When using this product
- wash hands after use with cool water
- avoid contact with eyes or mucous membranes
- do not bandage
Stop use and ask a doctor if
- condition worsens or symptoms persists for more than 7 days
- symptoms clear up and occur again within a few days
- excessive skin irritation occurs
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ABEJAS Y VIBORAS BRAND ROLL-ON
menthol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53145-703 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 mg in 100 mL Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) CARBOMER 940 (UNII: 4Q93RCW27E) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYL SALICYLATE (UNII: LAV5U5022Y) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53145-703-03 1 in 1 CARTON 03/01/2021 1 88 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2021 Labeler - MENPER DISTRIBUTORS INC. (101947166)