ANTIPHLAMINE: Package Insert and Label Information

ANTIPHLAMINE- camphor, (-)-, levomenthol and methyl salicylate patch
I World Pharmaceutical Co., Ltd.

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.

L-Menthol, L-Camphor, Methyl Salicylate

■ temporary relief aches and pains of muscles and joints associated with:

• arthritis • simple backache

• sprains • strains • bruises

Keep out of reach of children

■ Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily

■ children under 2 years of age: consult a doctor

Warnings

For external use only.

Flammable

■ 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

For external use only

acetone, chloroxylenol, water

label
(click image for full-size original)

ANTIPHLAMINE
l-menthol, l-camphor, methyl salicylate patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73442-0010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR, (-)- (CAMPHOR, (-)-) CAMPHOR, (-)- 59 mg in 1 g
LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL 8 mg in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 46 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ACETONE
CHLOROXYLENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73442-0010-2 7 PATCH in 1 POUCH contains a PATCH (73442-0010-1)
1 NDC:73442-0010-1 1.433 g in 1 PATCH This package is contained within the POUCH (73442-0010-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 09/09/2020
Labeler — I World Pharmaceutical Co., Ltd. (688222857)
Registrant — I World Pharmaceutical Co., Ltd. (688222857)
Establishment
Name Address ID/FEI Operations
I World Pharmaceutical Co., Ltd. 688222857 manufacture (73442-0010)

Revised: 09/2020 I World Pharmaceutical Co., Ltd.

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