ZAPNE- salicylic acid 0.5% cloth 
Zapne LLC

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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ZAPNE PRODUCT OTC DRUG LABEL

Directions:

WARNING: Avoid direct contact with eyes. If contact occurs, rinse thoroughly with water or other eye wash fuilds. If the problem persists, see a doctor immediately.

Dosage And Administration

Warnings: For external use only.

Using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one treatment should be used unless directed by a doctor. Avoid direct contact with eyes. If contact occurs, rinse thoroughly with water.

Keepy out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Side label

Other Ingredients

Natural Fresh Water Sponge(spongilla

lacustris), organic Aloe Vera, Natural

Sericin, Brown Seaweed, Organic Green

Tea, Organic Ginger Root, Willow Bark

(Salix alba), Organic Chamomile,

Propanediol, Decyl Glucoside, Citric

Acid, Potassium Sorbate, Hydrogen

Peroxide and Water

Inactive Ingredients

Indications: For the treatment of Acne

Indication

Keep out of reach of children: If swallowed, get medical help or contact a Poison Control Center immediately. Keep out of Reach of Children

Zapne

Acne Treatment System

Purpose

Active ingredients: salicylic acid 0.5% from natural willow bark extract

Active Ingredients

active ingredients

salicylic acid 0.5% from

natural willow bark extract

IndicationsFor the treatment of Acne
Other Ingredients

Natural Fresh Water Sponge(spongilla

lacustris), organic Aloe Vera, Natural

Sericin, Brown Seaweed, Organic Green

Tea, Organic Ginger Root, Willow Bark

(Salix alba), Organic Chamomile,

Propanediol, Decyl Glucoside, Citric

Acid, Potassium Sorbate, Hydrogen

Peroxide and Water

Store above freezing and below 100 F

Warnings: For external use only. Using other topical acne

medications at the same time or immediately following the use

of this product may increase dryness or irritation of the skin. If

this occurs, only one treatment should be used unless directed

by a doctor. avoid direct contact with eyes. If contact occurs,

rinse thoroughly with water.

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center immediately.

Does Not Contain: Benzoyl Peroxide, Parabens,

Phthalates, Sodium Lauryl/Laureth Sulfare, Sodium Methyl

Sulface, Artificial Colors or Fragrances

principal panel

ZAPNE 
salicylic acid 0.5% cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71024-105
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1300 mg
Inactive Ingredients
Ingredient NameStrength
SPONGILLA LACUSTRIS (UNII: 6SZ0G98BHM) 1261 mg  in 1300 mg
SILK SERICIN (UNII: 0N1VMU8G9W) 1.08 mg  in 1300 mg
NORI (UNII: 477TV3P5UX) 1.08 mg  in 1300 mg
GREEN TEA LEAF (UNII: W2ZU1RY8B0) 1.08 mg  in 1300 mg
GINGER (UNII: C5529G5JPQ) 1.08 mg  in 1300 mg
WILLOW BARK (UNII: S883J9JDYX) 1.08 mg  in 1300 mg
CHAMOMILE (UNII: FGL3685T2X) 1.08 mg  in 1300 mg
ALOE VERA LEAF (UNII: ZY81Z83H0X) 325 mg  in 1300 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71024-105-111 in 1 BOX10/01/2014
14 mg in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/01/2014
Labeler - Zapne LLC (080395104)
Registrant - Zapne LLC (080395104)
Establishment
NameAddressID/FEIBusiness Operations
Zapne LLC080395104repack(71024-105) , pack(71024-105) , manufacture(71024-105) , label(71024-105)

Revised: 10/2016
Document Id: 3e147e6b-a0a8-2fb0-e054-00144ff88e88
Set id: 3e147e6b-a0a7-2fb0-e054-00144ff88e88
Version: 3
Effective Time: 20161004
 
Zapne LLC