Label: ANTIPHLAMINE- l-menthol, l-camphor, methyl salicylate ointment
- 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.
Updated November 29, 2018
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
For external use only.
■ Keep away from fire, flame, sparks and heated surfaces. Tight cap firmly.
Stop use and ask a doctor if
■ Condition worsens or symptoms persist for more than 7days or clear up and occur again within a few days
When using this product
■ Use only as direct
■ Avoid contact with eyes
■ Do not apply to wounds or damaged skin
■ Do not bandage tightly
If pregnant or breast-feeding, ask a health professional before use
Keep out of reach of children
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
l-menthol, l-camphor, methyl salicylate ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72689-0015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)- 59 mg in 1 g LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 8 mg in 1 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 46 mg in 1 g Inactive Ingredients Ingredient Name Strength ACETONE (UNII: 1364PS73AF) CHLOROXYLENOL (UNII: 0F32U78V2Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72689-0015-1 30 g in 1 JAR; Type 0: Not a Combination Product 11/16/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 11/15/2018 Labeler - OASIS TRADING (689991468) Registrant - OASIS TRADING (689991468) Establishment Name Address ID/FEI Business Operations OASIS TRADING 689991468 manufacture(72689-0015)