SAFE HAIR by OLLA BOTANICAL COSMETIC IND. E COM. IMPORTACAO E EXPORTACAO EIRELI Safe Hair BZK Shampoo

SAFE HAIR by

Drug Labeling and Warnings

SAFE HAIR by is a Otc medication manufactured, distributed, or labeled by OLLA BOTANICAL COSMETIC IND. E COM. IMPORTACAO E EXPORTACAO EIRELI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SAFE HAIR GO PROTECTION- cleansing shampoo shampoo 
OLLA BOTANICAL COSMETIC IND. E COM. IMPORTACAO E EXPORTACAO EIRELI

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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Safe Hair BZK Shampoo

Active Ingredient(s)

Benzalkonium chloride 0.1 %

Purpose

Antiseptic

Use

For washing to decrease bacteria on the skin and hair.

Warnings

For external use only.

Do not use

in or near the eyes

on open skin wounds or burns

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Daily use to clean your hair, beard, and body skin. Apply it on wet hair, beard and body skin and massage it in circle movements for one minute and rinse it. Repeat if desired. For all hair types.
• Children under 6 years of age should be supervised when using this product.

Other information

Avoid freezing and store below 110F (43C).

Inactive ingredients

water, sodium laureth sulfate, glycerin, cocamidopropyl betaine, melaleuca alternifolia leaf oil, cocamide dea, phenoxyethanol, cymbopogon flexuosus oil, peg-150 distearate, sodium chloride, caprylyl glycol, glycol distearate, citric acid, guar hydroxypropyltrimonium chloride, laureth-4, disodium edta, polyquaternium-10, dmdm hydantoin, sodium citrate, aloe barbadensis leaf extract, benzoic acid, imidazolidinyl urea, magnesium nitrate, sodium benzoate, magnesium chloride, potassium sorbate, sodium acetate, methylchloroisothiazolinone, methylisothiazolinone, citral, eugenol, geraniol, limonene, linalool

Package Label - Principal Display Panel

300 mL NDC: 78727-123-03

SAFE HAIR  GO PROTECTION
cleansing shampoo shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78727-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
TEA TREE OIL (UNII: VIF565UC2G)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EUGENOL (UNII: 3T8H1794QW)
CITRAL (UNII: T7EU0O9VPP)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
LAURETH-4 (UNII: 6HQ855798J)
POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM ACETATE (UNII: 4550K0SC9B)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
IMIDUREA (UNII: M629807ATL)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
GERANIOL (UNII: L837108USY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78727-123-03	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2020
2	NDC: 78727-123-02	200 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/28/2020
3	NDC: 78727-123-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/28/2020	06/07/2021

Labeler - OLLA BOTANICAL COSMETIC IND. E COM. IMPORTACAO E EXPORTACAO EIRELI (894228823)

Establishment
Name	Address	ID/FEI	Business Operations
OLLA BOTANICAL COSMETIC IND. E COM. IMPORTACAO E EXPORTACAO EIRELI		894228823	manufacture(78727-123)

Revised: 6/2021

Document Id: c4333f79-bb15-083f-e053-2a95a90a5360

34390-5

Set id: a91f94af-2c9d-e01f-e053-2a95a90aa788

Version: 2

Effective Time: 20210607

 

OLLA BOTANICAL COSMETIC IN